36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) by HOWMEDICA OSTEONICS CORP.

Femoral neck fractures; .
Non-union of femoral head and neck fractures; .
Aseptic necrosis of the femoral head as well as;
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Indications for use as part of a Total Hip Replacement include:

Severely disabled joints resulting from painful osteo-, rheumatoid, post-traumatic arthritis ● and late stages of avascular necrosis;
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure as well as;
Other difficult clinical management problems.

Device Description

AI/ML Overview

The provided text from a Special 510(k) Premarket Notification for the "Addition of 36mm C-Taper Femoral Heads to the LFITTM and Non-LFITTM Series" does not contain information about acceptance criteria, device performance metrics, or study details as typically found in submissions for diagnostic or AI-driven medical devices.

This document is for a medical implant (femoral head components for hip replacement), and the regulatory pathway relies on demonstrating substantial equivalence to predicate devices already on the market, rather than meeting specific performance metrics from a clinical study using a separate test set.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or not present in this type of submission.

Here's a breakdown of why and what information can be extracted:

1. A table of acceptance criteria and the reported device performance:

Not Applicable in this context. For medical implants like this, "acceptance criteria" are typically related to material properties, dimensional tolerances, manufacturing processes, and biocompatibility, which are assessed against recognized standards (like ASTM F1537 for cobalt chromium alloy) rather than clinical performance metrics (like sensitivity, specificity) derived from a study on a "device performance" in terms of diagnostic accuracy. The reported "performance" is that the device functions as intended and is manufactured to the same specifications as the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Provided/Not Applicable. This submission is based on demonstrating substantial equivalence in design, materials, manufacturing, and intended use to previously cleared predicate devices. It does not involve a "test set" of patients or data in the sense of a clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. There is no "ground truth" establishment in this type of submission. The assessment is by FDA reviewers based on the engineering and design documentation comparing the new device to existing ones.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No test set or expert adjudication is involved.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is a hardware implant, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not Applicable.

8. The sample size for the training set:

Not Applicable. No training set for an algorithm is involved.

9. How the ground truth for the training set was established:

Not Applicable.

Summary of Relevant Information from the Provided Text:

The core of this submission is substantial equivalence to predicate devices. The arguments highlighted are:

Identical Intended Use: The subject device (36mm C-Taper Femoral Head) is intended for the same uses as the predicate devices (22-32mm C-Taper Femoral Head components). Indications for use are provided for Universal Hip Replacement (femoral neck fractures, non-union, aseptic necrosis, arthritis with minimal acetabular involvement) and Total Hip Replacement (severely disabled joints from arthritis/avascular necrosis, revision of previous procedures, other difficult clinical management).
Identical Manufacturing Methods, Materials, Packaging, and Sterilization: The new 36mm head uses the same processes and materials (cobalt chromium alloy conforming to ASTM F1537) as the existing, cleared femoral heads.
Predicate Devices:
- LFIT™ C-Taper femoral bearing components (K910988) up to +10mm offset head.
- Non-LFIT™ C-Taper femoral head components (K900836) up to +10mm offset head.
- +12mm and +15mm offset head components for both LFIT™ and non-LFIT™ versions (K982936).

Conclusion relevant to this specific document:

This submission is a "Special 510(k)" which signifies minor changes to a previously cleared device. The "study" proving it meets acceptance criteria is the demonstration that changing the size of the femoral head (from 22-32mm to 36mm) does not alter the fundamental safety or effectiveness because the materials, design principles, manufacturing, and intended use remain the same as legally marketed predicate devices. The "acceptance criteria" are implied by the FDA's decision to accept the claim of substantial equivalence, meaning the 36mm head performs equivalently to the cleared predicate devices within the context of hip replacement.

Summary

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Addition of 36mm C-Taper Femoral Heads to the LFITTM and Non-LFITTM Series

Special 510(k) Premarket Notification

MAY 2 1 2002

K021310

page 1 of 1

Special 510(k) Summary - Addition of 36mm C-Taper Femoral Heads To The LFIT™ And Non-LFITTM Series

	SUBJECT DEVICE	PREDICATE DEVICE
Proprietary Name:	36mm C-Taper Femoral HeadComponents (LFIT™ and Non-LFIT™)	22mm-32mm C-Taper FemoralHead Components (LFIT™ andNon- LFIT™)
Common Name:	Femoral Head Component	Femoral Head Component
Classification Name andReference:	21 CFR §888.3350Hip Joint Metal/ Polymer Semi-constrained Cemented Prosthesis	21 CFR §888.3350Hip Joint Metal/ Polymer Semi-constrained Cemented Prosthesis
Proposed Regulatory Class:	II	II
Device Product Code:	(87) JDI, LWJ, KWY	(87) JDI, LWJ, KWY
For Information contact:	Jennifer A. Daudelin, Regulatory AffairsHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677(201) 831-5379Fax: (201) 831-6038Email: idaudelin@howost.com

This Special 510(k) submission is intended to add 36mm C-Taper femoral head components to the LFTTM and non-LFTT™ Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The predicate LFTTM C- Taper femoral bearing components were found substantially equivalent via the 510(k) process in K910988 up to the size +10mm offset head. The non-LFIT™ C- Taper femoral head components were cleared in 510(k) number K900836 up to the size +10mm offset head. The +12mm and +15mm offset head components in both the non-LFIT™ and LFIT™ versions were found substantially equivalent in 510(k) #K982936. The C-Taper femoral head components are fabricated from cobalt chromium alloy conforming to ASTM F1537. Like the predicate devices, the subject devices are intended to be used in conjunction with appropriate Howmedica Osteonics hip stems in patients requiring total hip arthroplasty.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer A. Daudelin Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Re: K021310

Trade/Device Name: 36mm C-Taper Femoral Head Components (LFIT™ and Non-LFIT™) Regulation Number: 21 CFR 888.3350 and 21 CFR 888.3390

Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis and Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis

Regulatory Class: Class II Product Code: JDI, LWJ, and KWY Dated: April 24, 2002 Received: April 25, 2002

Dear Ms. Daudelin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Jennifer A. Daudelin

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Mark H. Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: 36mm C-Taper Femoral Heads

Indications for Use:

Indications for use as part of a Universal Hip Replacement include:

Femoral neck fractures; .
Non-union of femoral head and neck fractures; .
Aseptic necrosis of the femoral head as well as;
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Indications for use as part of a Total Hip Replacement include:

Severely disabled joints resulting from painful osteo-, rheumatoid, post-traumatic arthritis ● and late stages of avascular necrosis;
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure as well as;
Other difficult clinical management problems.

for Mark M. Milhurn
(Division Sign-C

Division of General. Restorative and Neurological Devices

510(k) Number _

) Number K021310

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use માં (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.