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Designation: F 1636 – 95e1

Standard Specification for


Bores and Cones for Modular Femoral Heads1
This standard is issued under the fixed designation F 1636; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.

e1 NOTE—Editorial changes were made throughout in December 1996.

1. Scope Surgical Implants (Special Quality)2


1.1 This specification covers the functional dimensions and F 562 Specification for Wrought Cobalt-Nickel-Chromium-
tolerances for tapered cones of proximal femoral stems and the Molybdenum Alloy for Surgical Implant Applications2
bores of mating ceramic and metal heads. F 563 Specification for Wrought Cobalt-Nickel-Chromium-
1.2 This specification does not cover the dimensions of Molybdenum-Tungsten-Iron Alloy for Surgical Implant
proximal femoral stems other than the cone portion, nor does it Applications2
cover the dimensions of the ceramic/metal femoral heads, other F 603 Specification for High-Purity Dense Aluminum Ox-
than the inside tapers. ide for Surgical Implant Application2
1.3 The dimensions stated in SI units are to be regarded as F 620 Specification for Titanium 6Al, 4V ELI Alloy Forg-
the standard. ings for Surgical Implants2
1.4 The purpose of this specification is to codify matching F 621 Specification for Stainless Steel Forgings for Surgical
bore and cone combinations for easy identification. Nonethe- Implants2
less, components from different manufacturers should not be F 799 Specification for Thermomechanically Processed
mixed because the combinations of tolerances within the Cobalt-Chromium-Molybdenum Alloy Forgings for Surgi-
family, surface finish, and configuration from the different cal Applications2
manufacturers may not have been validated through axial load F 961 Specification for Cobalt-Nickel-Chromium-
strengths or fatigue strength. Information supplied by the Molybdenum Alloy Forgings for Surgical Implant Appli-
manufacturer with the implants should include a precaution cations2
statement that informs the user (surgeon) that bores and cones F 1108 Specification for Ti-6Al, 4V Alloy Castings for
with the same code letter from different manufacturers should Surgical Implants2
not be used without first consulting the supplier of the femoral 3. Terminology
components.
1.5 The codification described in this specification repre- 3.1 Definitions:
sents the most current state of the art at the time of balloting. 3.1.1 nominal neck length—the distance, K, parallel to the
Future additions can be made but because of the time required taper axis, between the theoretical gage point and the horizon-
to revise the specification, it is recommended that the manu- tal plane through the center of the head; this distance does not
facturer of new combinations label their components with at include standard variants used to adjust for resection level, leg
least the angles until such time that new code letters can be length, and so forth. The K dimension may be plus or minus
established in accordance with future revisions of this specifi- (proximal or distal to the location of the theoretical gage Point
cation. G).
3.1.2 residual or free length—the distance, A, parallel to the
2. Referenced Documents cone axis, between the end of the cone and the theoretical gage
2.1 ASTM Standards: point.
F 75 Specification for Cast-Cobalt-ChromiumMolybdenum 3.1.3 theoretical gage point—the diameter, G, at nominal
Alloy for Surgical Implant Applications2 tolerance, where the stem cone (external taper) theoretically
F 136 Specification for Wrought Titanium 6A1, 4V ELI engages the femoral head bore (internal taper).
Alloy for Surgical Implant Applications2
4. Materials
F 138 Specification for Stainless Steel Bar and Wire for
4.1 The cones may be made from any of the implantable
grade materials used for femoral stems including: Specifica-
1
This specification is under the jurisdiction of ASTM Committee F-4 on Medical tions F 75, F 136, F 138, F 562, F 563, F 620, F 621, F 799,
and Surgical Materials and Devices and is under the direct responsibility of F 961, and F 1108.
Subcommittee F04.22 on Arthroplasty.
Current edition approved Dec. 10, 1995. Published June 1996. 4.2 The ceramic heads may be made from Specification
2
Annual Book of ASTM Standards, Vol 13.01. F 603 or a material determined to be substantially equivalent or

Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.

1
F 1636
superior in mechanical strength, wear properties, and biocom- TABLE 1 Cones
patibility. The metal heads may be made from any of the a° Size
G—Diameter, A—Dimension,
recognized materials used for femoral stems including: Speci- mm mm

fications F 75, F 136, F 138, F 562, F 563, F 620, F 621, F 799, 2° 508 309, 6509 A 12.8 1.0
3° 48 09, 668 B 10.98 2.54
F 961, and F 1108. 4° 08 09, 62.58 C 11.5 1.0
4° 08 09, 61.68 D 13.3 1.0
5. Dimensions and Finish 5° 08 09, 638 E 12.7 2.34
5° 358 308, 628 F 11.75 0.0
5.1 The cone dimensions shall be as indicated in Fig. 1 and G 9.6 1.4
Table 1. A gaging system should be utilized to ensure that H 10.3 1.0
J 11.1 1.0
mating diameters of the cone will allow proper seating of the 5° 408, +2.58 K 11.87 5.75
femoral head. L 12.7 1.0
5.2 The inside taper of the femoral head shall have the M 12.7 1.4
N 12.7 1.4
dimensions as indicated in Fig. 2 and Table 2. It is important P 14.3 1.0
with ceramic heads that the tip of the cone reside in the relief Q 14.3 1.4
of the head on final assembly. R 10.98 0.5
S 11.082 1.5
5.3 The finish of the cone may be textured, machined, 5° 438 309, 628 T 11.2 2.7
ground, or roughened surface. The adequacy of this surface U 11.082 3.0
finish shall be tested for the axial strength of the head and the V 11.082 1.501
W 11.082 1.502
pull-off load. 6° 08 009, +18−08 X 10.69 5.12
Y 10.1 1.0
6° 08 009, −18 −58 Z 10.9 1.0
6. Marking
AA 12.5 1.0
6.1 Each cone and head shall be marked with the appropri- BB 14.1 1.0
6° 08 009, 648 CC 10.69 5.12
ate size letter to designate matching bores and cones and, 6° 218 348, +08−58 DD 12.0 7.0
where possible, the manufacturer’s code or logo. 11° 258 009, +18−28 EE 11.1 3.8

FIG. 2 Bores

7. Keywords
7.1 bores; ceramic; cones; dimensions; femoral heads; fin-
ish; marking; metal; sizes
FIG. 1 Cones

2
F 1636
TABLE 2 Bores
G—Diameter, K = Nominal
b° Size
mm Neck, mm
2° 528 209, +28−08 A 12.9 4.2
3° 28 009, 648 B 10.98 3.38
4° 08 009, +5.68 −5.28 C 11.5 1.5
4° 08 009, 648 D 13.25 2.3
5° 08 009, 658 E1 12.4 7.81
5° 88 009, 638 E2 12.4 7.28
5° 438 309, 628 F 11.8 4.0
G1 9.6 1.7
5° 438 309, +58−08 G2 9.6 3.7
H 10.3 7.3
J 11.1 5.4
5° 408 009, +38 409−08 K 11.87 0.0
L 12.7 2.8
M 12.7 2.6
5° 438 309 +58 −08 N 12.7 2.9
P 14.3 7.3
Q1 14.3 2.7
Q2 14.3 3.0
R 10.98 4.0
5° 518 309, 628 S 11.082 1.0
T 11.2 −1.8
U 11.23 3.5
6° 08 009, +28 V 11.082 5.0
6° 88 309, +28 W 11.082 5.0
6° 08 009, 608 −18 X1 10.69 −4.5
X2 10.69 −0.07
Y 10.1 −7.5
6° 08 009, +18 +58 Z 10.9 3.6
AA 12.5 3.6
BB 14.1 7.5
6° 08 009, +48 CC1 10.69 −4.5
CC2 10.69 −0.07
6° 218 349, +58 −08 DD 12.0 0.0
11° 258 009, +18 −58 EE 11.5 2.0

APPENDIX

(Nonmandatory Information)

X1. RATIONALE

X1.1 Ceramic aluminum oxide (Al2O3) heads have been cone are important to both the axial fracture loads of ceramic
successfully used on modular femoral stems since 1974. Their heads and the security of the seating of the head on the cone.
success has been the result of the high purity ceramic in Axial pull-off loads are utilized to evaluate the adequacy of the
conjunction with the mating characteristics of the inside taper tenacity of the fit between the head and the cone.
of the head and those of the matching cones. When these
characteristics are optimum, the axial fracture loads for the X1.3 Angular and dimensional differences in cones can
ceramic heads exceed 40 KN (45 times the body of a 200-lb significantly affect the axial fracture load of ceramic modular
person) and exceed the anatomical load carrying capabilities of heads. Therefore, it is necessary to classify the taper cone
femoral stems by at least a factor of two. Modular metal heads angles and dimensions and surface roughness to ensure proper
have been used successfully since 1982. function of modular heads and modular femoral stems.
X1.2 The dimensional and surface characteristics of the

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F 1636

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