IS 12376-1: Implants for surgery - Femoral tibial components for partial and total knee joint prostheses, Part 1: Classifcation, definitions and designation of dimensions

14 Pages·1997·1.2 MB·English

by  Bureau of Indian Standards

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IS 12376-1 (1997): Implants for surgery - Femoral tibial
components for partial and total knee joint prostheses,
Part 1: Classifcation, definitions and designation of
dimensions [MHD 2: Orthopaedic Instruments, Implants and
Accessories]
“!ान $ एक न’ भारत का +नम-ण”
Satyanarayan Gangaram Pitroda
““IInnvveenntt aa NNeeww IInnddiiaa UUssiinngg KKnnoowwlleeddggee””
“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता हहहहै””ै”
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”

IS 12376 (Part 1) : 1997
IS0 7207-l : 1994
vn9vm5

STNALPMI FOR YREGRUS - LAROMEF DNA
LAIBIT STNENOPMOC FOR LAITRAP DNA
LATOT EENK TNIOJ SESEHTSORP
PART 1 CLASSIFICATION, DEFINITIONS AND DESIGNATION OF DIMENSIONS
( First Revision )
ICS 11 mo.40

@ BIS 1997
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
October 1997 Price &up 4
Orthopaedic Instruments and Accessories Sectional Committee, MHD 2
NATIONAL FOREWORD
This Indian Standard (Part l)(First Revision) which is identical with IS0 7207-l : 1994 ‘Implants for
surgery - Femoral and tibia1 components for partial and total knee joint prostheses - Part 1 :
Classification, definitions and designation of dimensions’ issued by the International Organization
for Standardization (ISO), was adopted by the Bureau of Indian Standards on the recommendations
of Onhopaedic Instruments and Accessories Sectional Committee and approval of the Medical
Equipment and Hospital Planning Division Council.
This standard IS 12376 (Part 1) was published in 1987 as dual number standard based on IS0 7207-
1 : 1985. Its first revision has been issued to incorporate the modifications effected in the second
edition of IS0 7207-l brought out in 1994. In this revised version a number of definitions have either
been replaced or modified with the new definitions to suit the profession. Certain nomenclature have
also been changed.
The text of above mentioned IS0 standard has been approved as suitable for publication as Indian
Standard without deviations. Certain conventions are, however, not identical to those used in Indian

Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should
be read as ‘Indian Standard’.
b) Comma (J has been used as a decimal marker while in Indian Standards, the current practice
is to use a point (.) as the decimal marker.
For the purpose of deciding whether a particular requirement of this standard is complied with, the
final value, observed or calculated, expressing the result of a test, shall be rounded off in accordance
with IS 2 : 1960 ‘Rules for rounding off numerical values (revised)‘. The number of significant places
retained In the rounded off value should be the same as that of the specified value in this standard.
IS 12376 (Part1 ) : 1997
IS0 7207-l : 1994
Indian Standard
STNALPMI FOR YREGRUS -.FEMORAL DNA
LAIBIT STNENOPMOC FOR LAITRAP DNA
LATOT EENK TNIOJ SESEHTSORP
*P ART 1 CLASSIFICATION, DEFlNlTiGNS AND DESIGNATION OF DIMENSIONS
( First Revision )
compartment fo eht eenk ees( erugif ,1 snoitisop A
1 Scope
dna C, or B dna D).
sihT trap fo 0SI 7027 seifissalc laromef dna 1aibit
stnenopmoc rof eenk tnioj sesehtsorp ni hcihw. eno 4.2 total replacement of the knee joint: erudecorP
or htob gniraeb secafrus fo ta tsael eno compartment fo gnicalper eht laromef dna 1aibit gniraeb secafrus ni
fo eht eenk era ,decalper dna sevig snoitinifed fo htob compartments fo eht eenk ees( erugif ,1 -sop
stnenopmoc dna eht noitangised fo .snoisnemid snoiti ,A ,B C dna D).
ralletaP stnenopmoc dna sesehtsorp taht edulcni na ETON 2 noisivorP rof noitalucitra htiw eht alletap may or
desopretni gnitaolf tnenopmoc era ton dedulcni ni siht may ton eb .dedivorp
trap fo 0SI .7027
5.2 non-constrained total knee joint prosthesis:
latoT eenk tnioj sisehtsorp ni hcihw ereht si on

2 Definitions lacinahcem tnemhcatta neewteb eht 1aibit dna

laromef stnenopmoc dna hcihw swolla tnemevom ni
For eht sesoprup fo siht trap fo 0SI ,7027 eht -wollof lla eerht senalp ees( serugif ,2 3 dna .14
gni snoitinifed .ylppa
6.2 partially-constrained total knee joint pros-
2.1 partial unicompartmental knee joint compo- thesis: latoT eenk tnioj sisehtsorp gnivah some
nent: sisehtsorP dengised ot ecalper eht gniraeb -rus lacinahcem tniartsnoc neewteb eht 1aibit dna laromef
ecaf fo eno elydnoc fo rehtie eht rumef or eht aibit stnenopmoc dna hcihw swolla tnemevom ni more
ees( erugif ,1 noitisop ,A ,B C or D). naht eno enalp ees( .)5erugif
2.2 partial bicompartmental knee joint compo- 7.2 ftilly-constrained total knee joint prosthesis:
nent: sisehtsorP dengised ot ecalper eht gniraeb -rus latoT eenk tnioj sisehtsorp ni hcihw eht owt strap era
secaf fo htob selydnoc fo rehtie eht rumef or eht aibit yllacinahcem detalucitra dna hcihw swolla tnemevom
ees( erugif ,1 snoitisop A dna ,B or C dna D). yllapicnirp ni eno enalp ees( erugif .)6
NOTE 1 nI lacigrus ecitcarp ralydnocinu stnenopmoc may
eb desu rehtie rof ralydnocinu ,stnemecalper rof 8.2 effective bone resection distance: muminiM
ecnatsid neewteb detceser secafrus fo eht rumef
latnemtrapmocinu ,stnemecalper or rof latot ,stnemecalper
ro/dna aibit ni tcatnoc htiw eht )x(uaetalp fo eht im-
saerehw yllareneg ralydnocib stnenopmoc era desu ylno rof
latot eenk tnioj .tnemecalper .tnalp 9
3.2 unicompartmental partial knee joint replace- 9.2 stem: traP fo ralydnocib tnenopmoc dengised ot
ment: erudecorP fo gnicalper eht gniraeb secafrus fo retne eht yralludem ytivac ees( serugif ,2 5 dna ,6 -id
eht suougitnoc selydnoc fo eht rumef dna aibit ni eno snoisnem t dna .IJ
IS 12376 ( Part 1) : 1997
ISO 7207-l : 1994
2.10 femoral stem angle: etucA elgna neewteb eht a) ralydnocinu ees( )4erugif
sixa fo eht laromef stem dna eht ralucidneprep ot eht
,uaetalp sa deweiv ni eht roiretsop-oretna .noitcerid 1) laromef
2) 1aibit
NOTE 3 ehT noitcerid fo siht elgna senimreted rehtehw
eht sisehtsorp dluohs eb desu ni eht thgir ro tfel gel fo eht b) ralydnocib ees( serugif ,2 ,3 5 dna 6)
.tneitap
)I laromef
11.2 tibia1 stem angle: etucA elgna neewteb eht 2) 1aibit
sixa fo eht 1aibit mets dna eht ralucidneprep ot eht
,uaetalp sa deweiv ni eht roiretsop-oretna .noitcerid
2.12 intracondylar projection: noitroP fo ralydnoc 2.3 ehT dednetni esu fo eht sesehtsorp llahs eb
tnenopmoc rof gnitacol dna gnixif eht tnenopmoc jr, derfrssalc sa :swollof
eht elydnoc ees( serugif 3 dna ,4 snoisnemid r, dna
r\ a! laitrap tnioj tnemecalper
2.13 over31 width: mumixaM noisnemid nI eht )I ralydnocinu
esrevsnart enalp ees( serugif 2 ot ,5 noisnemid .)1~ 2) latnemtrapmocinu
2.14 overall depth: mumixaM noisnemid ni eht b) latot tnioj tnemecalper
roiretsop-oretna enalp htiw eht tnioj ylluf dednetxe
ees( serugif 2 ot ,5 noisnemid .)d
2.15 implant plateau: tahT trap fo eht tnenopmoc 3.3 For latot tnioj tnemecalper eht delbmessa com-
ni tcatnoc htiw detcesnart enob ro/dna enob .tnemec stnenop llahs eb deifissalc gnidrocca ot eht noitcnuf
fo eht tnioj ni eht dedaolnu noitidnoc sa :swollof
2.16 bone plateau: detcesnarT ecafrus fo eht enob
hcihw may eb ni tcatnoc htiw eht uaetalp fo eht im- a) deniartsnoc-non ees( serugif ,2 3 dna 4)
tnalp ro/dna enob .tnemec b) yllaitrap deniartsnoc ees( erugif 5)
c) ylluf deniartsnoc ees( )6erugif
2.17 patella bearing surface: ’ecafruS taht si -ni
dednet ot etalucitra htiw eht alletap or gnicafruser

tnenopmoc fo eht .alletap

81.2 femorotibial bearing surface: esohT saera 4 Designation of dimensions
hguorht hcihw daol si dettimsnart from eht laromef ot
eht 1aibit .tnenopmoc ehT snoisnemid fo laitrap dna latot eenk tnioj
sesehtsorp llahs eb detangised ni ecnadrocca htiw
serugif ,2 ,3 4 or 5 sa .etairporppa
3 Classification
NOTE 4 serugiF 2 ot 6 era dednetni ot eb evitartsulli fo
3.1 sesehtsorP desu ot ecalper emos ro lla fo eht lacipyt eenk tnioj sesehtsorp dna ot etangised snoisnemid
gniraeb secafrus ni eht eenk tnioj llahs eb deifissalc dna etartsulli ,erutalcnemon tub noitatnestrper fo eht -moc
sa :swollof stnenop seod ton esiwrehto mrof trap fo 0SI .7027
2
IS 12376 (Part 1 ) : 1997
IS0 7207-l : 1994
Femur
- Tibia

Key:
,A B noitisoP fo ralydnoc sesehtsorp no eht rumef
C, D 1aibiT uaetalp sesehtsorp
NOTE - esehT yam eb laidem ro .laretal
Figure 1 - Human knee joint showing positions in which condylar prostheses may be used
IS 12376 (Part 1 ) : 1997
IS0 7207-l : 1994
Femoral intra-
+ medullary stem
l- Femoral plateau
Patella bearing
surface kqhonal) 7 I
I
Femoral bearing
surface

r Tibia1 plateau
T&id intra-
medullary stem
Key:
t mets 1aibit( mets )htgnel
d llarevo htped
w llarevo htdiw
f mets laromef( mets )htgnel

Figure 2 - Typical non-constrained bicondylar total knee joint prothesis with intramedullary stems
(see eton 4)
SI 67321 (Part 1) : 1997
IS0 7207-l : 1994
Patek bearing
surface (optional)

-
i
L- Femoral plateau
d _ 1
EI’
t 01 0
I 1$
Tibiil plateau
I/
0
j/ %A --A
Key:
d llarevo htped Pt htgnel fo 1aibit ralydnocartni noitcejorp ’
pf htgnel fo laromef ralydnocartni noitcejorp w llarevo. htdiw

Figure 3 - Typical non-constrained bicondylar total knee joint prosthesis with intracondyiar projections,
and patella bearing surface (optional) (see eton 4)
5