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 by other techniques.
Revision of previous failed total hip arthroplasty.

The Parallel-Sided Extensively Coated Femoral Stems are for uncemented applications only.

Device Description

The Parallel-Sided Extensively Coated Femoral Stem is designed to replace the patural femoral hip component due to disease or accident. The femoral hip prosthesis is made from wrought titanium alloy (Ti-6AI-4V) (ASTM F136) and has a porous coat, designed to be used in uncemented applications. The stem diameters and lengths are within the range of the previously cleared predicates. In addition to the cylindrical stem design, the Parallel-Sided Extensively Coated Femoral Stem offers a lateralized offset for optimal patient fit.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Parallel-Sided Extensively Coated Femoral Stem" device. Upon review of the document, the following observations can be made regarding acceptance criteria and supporting studies:

Acceptance Criteria and Reported Device Performance:

The document does not explicitly define specific quantitative acceptance criteria for the device's performance. Instead, it states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This approach is typical for 510(k) submissions, where the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device rather than meeting pre-defined quantitative performance thresholds.

Acceptance Criteria	Reported Device Performance
Demonstration of "substantial equivalence" to predicate devices (Reach® Revision System- K982367, AML® Hip Stem- K012364, XR-Series Bi-Metric® Femoral Stems- K052089)	"The technological characteristics (materials, design, sizing, and indications) of the Parallel-Sided Extensively Coated Femoral Stem are similar or identical to the predicate devices or to other previously cleared devices."
"Functional within its intended use" based on non-clinical testing. (Intended use: femoral hip component replacement due to disease or accident, uncemented applications).	"Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." (However, specific performance metrics or thresholds are not detailed in this summary).
Material composition (wrought titanium alloy (Ti-6AI-4V) (ASTM F136)) and porous coating for uncemented applications.	The device is made from "wrought titanium alloy (Ti-6AI-4V) (ASTM F136)" and "has a porous coat, designed to be used in uncemented applications."
Stem diameters and lengths within the range of previously cleared predicates.	"The stem diameters and lengths are within the range of the previously cleared predicates."
Presence of a lateralized offset (as an additional feature).	"In addition to the cylindrical stem design, the Parallel-Sided Extensively Coated Femoral Stem offers a lateralized offset for optimal patient fit." (This is a design feature, not a performance metric per se, but supports "optimal patient fit" as an intended functional outcome).

Sample size used for the test set and the data provenance:

The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means there was no human-patient-based test set with associated data provenance for this specific 510(k) submission. The evaluation relied solely on non-clinical (laboratory) testing and comparison to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set was used, and therefore, no expert-established ground truth for a test set was required for this submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set was used.
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 device is a physical orthopedic implant, not an AI or imaging diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to its evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical orthopedic implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "non-clinical laboratory testing," the ground truth would be established by engineering standards, material specifications, mechanical testing protocols (e.g., fatigue, static strength, wear), and performance benchmarks derived from the predicate devices. This would involve objective measurements and comparisons against established industry and regulatory standards for orthopedic implants.
The sample size for the training set:

Not applicable in the context of clinical data for AI/ML. For the non-clinical testing, the "sample size" would refer to the number of devices tested in laboratory experiments (e.g., how many stems were subjected to fatigue testing). This information is not provided in the summary.
How the ground truth for the training set was established:

Not applicable in the context of clinical data for AI/ML. For the non-clinical testing, the "ground truth" or validation data would be established through adherence to national and international standards for medical device testing (e.g., ASTM, ISO standards for hip implants), recognized testing methodologies, and comparison to the known performance characteristics of the predicate devices.

Summary

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K073637 page '92

MAR 2 0 2008

Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics, Inc. The logo is in black and white and features the word "BIOMET" in a stylized font with a superscripted "3". Below the word "BIOMET" is the text "ORTHOPEDICS, INC." in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's products, website, and marketing materials.

510(k) Summary

Parallel-Sided Extensively Coated Femoral Stem

Preparation Date: December 21, 2007

Biomet Manufacturing Corp. Applicant/Sponsor:

Elizabeth Wray Contact Person:

Parallel-Sided Extensively Coated Femoral Stem Proprietary Name:

Hip ioint femoral replacement device Common Name:
Classification Name: - Class II, 21 CFR §888.3358, §888.3350, and §888.3353.

The mating components (modular heads and acetabular shells/liners) for use with the Parallel-Sided Extensively Coated Femoral Stem have the following classifications:

Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (888.3310) �
Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (888.3350)
Prosthesis, Hip, Semi-constrained, Metal/Ceramic/Polymer, Cemented or Non-porous, Uncemented (888.3353)
Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous, Uncemented (888.3358) .
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented (888.3390)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Reach® Revision System- K982367, 08/24/98 (Biomet Inc.) AML® Hip Stem- K012364, 10/19/01 (DePuy Inc.) XR-Series Bi-Metric® Femoral Stems- K052089, 02/17/06 (Biomet Inc.)

Device Description:

P.O. Box 587
Warsaw IN 46581-0557
Toll Free: 800 348 9500
Office 574 767 6539
Main Fax 574 267.8137
www.biomet.com

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Indications for Use/Intended Use:

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

The Paraliel-Sided Extensively Coated Femoral Stems are for uncemented applications only.

Summary of Technologies:

The technological characteristics (materials, design, sizing, and indications) of the Parallel-Sided Extensively Coated Femoral Stem are similar or identical to the predicate devices or to other previously cleared devices.

Non-Clinical Testing:

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

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc., except for AML®, which is a trademark of DePay, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.

MAR 2 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. c/o Ms. Elizabeth Wray Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K073637 Trade/Device Name: Parallel-Sided Extensively Coated Femoral Stems Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LPH, JDI, KWY, KWZ Dated: December 21, 2007 Received: December 26, 2007

Dear Ms. Wray:

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. Elizabeth Wray

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), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mulhausen

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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Page 1 of

Indications for Use

510(k) Number (if known): __ Koフふん3 7

Device Name:

Indications for Use:

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

The Parallel-Sided Extensively Coated Femoral Stems are for uncemented applications only.

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)

Souther
(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

510(k) Number K073637

4 - 1

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.