GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER by BIOMET MANUFACTURING, INC.

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid Arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Revision of previously failed total hip arthroplasty.

The Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer is intended for cemented use only and may be used in partial and total hip arthroplasties.

Device Description

The Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer is designed to replace the patient's natural hip femoral neck and head damaged due to disease or accident. The femoral hip prosthesis is made from forged Co-Cr-Mo per ASTM F799, and the proximal cement spacers are made from polymethylmethacrylate (PMMA). The implants are designed for use with bone cement. General implant surfaces are highly polished. In addition to the proximal cement spacer, an optional distal cement centralizer (cleared in K942479) is available for optimum stem placement within the canal.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies for the Generation 4® Polished Femoral Hip System with Proximal Cement Spacer:

This device is not an AI/ML powered device, hence information regarding "AI/ML" is not applicable/not found.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific thresholds for strength, durability, or clinical outcomes). Instead, the acceptance criteria are implicitly met through the demonstration of substantial equivalence to legally marketed predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary of Evidence)
Substantial Equivalence to legally marketed predicate devices in:	- Materials: Manufactured from the same materials (forged Co-Cr-Mo per ASTM F799 for femoral component, PMMA for cement spacers) as other cleared femoral hip prostheses.
- Manufacturing Practices: Utilizes the same manufacturing practices as other cleared femoral hip prostheses.
- Conforms to Standards: Conforms to the same standards as other cleared femoral hip prostheses.
- Intended Use/Functionality: Non-clinical laboratory testing indicated the device was functional within its intended use.
Safety and Effectiveness (demonstrated through substantial equivalence)	- No adverse safety or effectiveness concerns raised by the FDA (as indicated by 510(k) clearance).
Indications for Use: The stated indications for use are similar to those of predicate devices.	- The device is indicated for non-inflammatory degenerative joint disease, Rheumatoid Arthritis, correction of functional deformity, treatment of certain femoral fractures, and revision of failed total hip arthroplasty, for cemented use only.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "test set" in the context of clinical data, as no clinical testing was necessary for the determination of substantial equivalence (as stated in the "Clinical Testing" section).
Data Provenance: The primary "data" for demonstrating substantial equivalence comes from comparisons with existing, legally marketed predicate devices, and non-clinical laboratory testing. The provenance of this non-clinical data is not detailed (e.g., country of origin, retrospective/prospective), but it would have been conducted internally or by a contracted lab.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as no clinical test set requiring expert ground truth establishment was used for the 510(k) submission. The FDA review process itself involves expert evaluation by agency staff, but this is distinct from experts establishing ground truth for a device's specific test set.

4. Adjudication Method for the Test Set

This is not applicable as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical testing was necessary for determination of substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This is not applicable as the device is a physical hip prosthesis, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of a 510(k) submission, is effectively the established safety and effectiveness of the identified predicate devices, combined with the results of non-clinical laboratory testing demonstrating the device's functional performance and equivalence in materials and manufacturing.
- Predicate Device Performance: Historical clinical performance and regulatory clearances of the predicate devices (Generation 4® Polished Femoral Hip Prosthesis, A Rx-90™ Femoral Stems, A Rx-90™ Femoral Component) serve as the primary benchmark.
- Non-Clinical Testing: Laboratory tests (e.g., mechanical testing, materials characterization) provide the ground truth for the physical and mechanical properties of the new device itself.

8. The Sample Size for the Training Set

This is not applicable. As a physical medical device and not an AI/ML system, it does not involve a "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles, material science, and the existing knowledge base from previous device designs (predicate devices).

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

Summary

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510(k) Summary K052639

Preparation Date:

Applicant/Sponsor:

Proprietary Name:

Classification Name:

April 12, 2006

Biomet Manufacturing Corp.

MAY 3 2006

Contact Person: Susan Alexander

Generation 4® Polished Femoral Hip System with Proximal Cement Spacer

Common Name: Prosthesis, Hip, Femoral Component, Cemented, Metal

The Generation 4® Polished Femoral Hip Prosthesis has the following classification: Class II, 21 CFR §888.3350.

The mating components (modular heads and acetabular shells/liners) for use with the Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer have the following classifications:

Hip joint metal/polymer constrained cemented or 1. uncemented prosthesis (21 CFR $888.3310), Product Code: KWZ

1. Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFRS 888.3350), Product Code: JDI
1. Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR$ 888.3360), Product Code: JDG
1. Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353), Product Code: MEH
Hip joint metal/polymer/metal semi-constrained, porous-ട്. coated, uncemented prosthesis (21 C.F.R. §888.3358), Product Code: LPH
Hip joint (hemi-hip) acetabular metal cemented ల్. prosthesis (21 CFR §888.3370), Product Code: LZY
7 . Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR58888.3390), Product Code: KWY
1. Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353), Product Code: LZO

MAILING ADDRESS	SHIPPING ADDRESS
P.O. Box 587	56 E. Bell Drive
Warsaw, IN 46581 0587	Warsaw, IN 46582

OFFICE	574.267.66.39
FAX	574.267.8157
E-MAIL	biomet@biomet.com

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510(k) Summary Generation 4 Polished Femoral Hip Prosthesis with Cement Spacer Page 2 of 3

Legally Marketed Devices to Which Substantial Equivalence Is Claimed:

Generation 48 Polished Femoral Hip Prosthesis - Biomet Manufacturing Corp. (K031734)
A Rx-90™ Femoral Stems and Lateralized Stems - Biomet Manufacturing Corp. (K023085)
A Rx-90™ Femoral Component - Biomet, Inc. (K942028)

The Generation 48 Polished Femoral Hip Prosthesis with Device Description: Proximal Cement Spacer is designed to replace the patient's natural hip femoral neck and head damaged due to disease or accident. The femoral hip prosthesis is made from forged Co-Cr-Mo per ASTM F799, and the proximal cement spacers are made from polymethylmethacrylate (PMMA). The implants are designed for use with bone cement. General implant surfaces are highly polished. In addition to the proximal cement spacer, an optional distal cement centralizer (cleared in K942479) is available for optimum stem placement within the canal.

The indications for use for the Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer include:

Non-inflammatory degenerative joint disease 1 including osteoarthritis and avascular necrosis.
Rheumatoid Arthritis. 2.
1. Correction of functional deformity.
Treatment of non-union, femoral neck র্বা fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques.
ક. Revision of previously failed total hip arthroplasty.

The Generation 48 Polished Femoral Hip Prosthesis with Proximal Cement Spacer is intended for cemented use only and may be used in partial and total hip arthroplasties.

The Generation 48 Polished Femoral Hip System is manufactured from the same materials, utilizing the same manufacturing practices, and conforming to the same standards as other femoral hip prostheses cleared for cemented use.

Indications

Summary of Technologies:

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510(k) Summary Generation 4 Polished Femoral Hip Prosthesis with Cement Spacer Page 3 of 3

Non-Clinical Testing:

Clinical Testing:

Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

No clinical testing was necessary for determination of substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 23 2009

Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Specialist P. O. Box 587 Warsaw, Indiana 46581-0587

Re: K052639

Trade/Device Name: Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI, LZO, KWZ, MEH, LPH, KWY, JDG Dated: April 12, 2006 Received: April 13, 2006

Dear Ms. Alexander:

This letter corrects our substantially equivalent letter of May 3, 2006.

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 (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 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

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Page 2 - Ms. Susan Alexander

limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchele
for MXM

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K052639

Device Name: Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer

The indications for use for the Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer include:

Non-inflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis.
1. Rheumatoid Arthritis.
1. Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of 4. the proximal femur with head involvement, unmanageable using other techniques.
1. Revision of previously failed total hip arthroplasty.

The Generation 4® Polished Femoral Hip Prosthesis with Proximal Coment Spacer is intended for cemented use only and may be used in partial and total hip arthroplasties.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Claraa Buelund

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K052639

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.