NARROW ASCENT INTERLOK FEMORAL COMPONENTS

• K Number: K024037
• Device Name: NARROW ASCENT INTERLOK FEMORAL COMPONENTS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2002-12-30 ( 24 days)
• Product Code: JWH
• Regulation Number: 888.3560
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K982869
• Predicate For: N/A

Intended Use

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure.
   The device is indicated for implantation with cement.

Device Description

The Narrow Ascent™ Interlok® Femoral Components are primary femoral components intended for use with an Ascent™ tibial component and patella for total knee replacement. The device is manufactured from cast cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75 with Biomet's Interlok®, 30 grit blasted finish. Three sizes, x-small, small, and medium are available in left and right configurations.
The device varies from the predicated device in that the width of the component in the medial-lateral direction has been reduced by approximately 4mm. This has been accomplished by reducing the width of each condyle by approximately 2mm. All other dimensions remain the same. A narrower femoral component is desired to avoid overhang of the device in a patient with a naturally narrow femur.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Narrow Ascent™ Interlok® Femoral Components:

Summary of Acceptance Criteria and Device Performance:

The provided document, a 510(k) premarket notification for the Narrow Ascent™ Interlok® Femoral Components, does not explicitly state specific quantitative acceptance criteria or a clinical study proving the device meets them. Instead, the basis for clearance is substantial equivalence to a previously cleared predicate device (Ascent™ Primary Interlok® Femur, K982869).

The "acceptance criteria" in this context are implicitly met by demonstrating that the modifications to the device (reduced width) do not compromise safety and effectiveness when compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: Materials used for the device must be the same as or similar to the predicate device.	"The materials, design and processing of the modified device are identical to or similar to the predicate." (Section {1})
Design Equivalence (functional): The design modification (reduced width) must maintain the functional integrity and strength of the component.	"Engineering analysis was provided to demonstrate that the design change would not compromise the strength of the component." (Section {1})
Intended Use Equivalence: The device's intended use must be the same as the predicate device.	The stated "Intended Use" (Section {1} and {4}) is consistent with typical knee replacement indications. This aligns with the understanding that the new device is a narrower version of the existing one, thus serving the same purpose for patients with narrower femurs.
Overall Safety and Effectiveness: The device must be safe and effective for its intended use, comparable to the predicate.	The FDA determined the device is "substantially equivalent... to legally marketed predicate devices." (Section {2})

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

• Sample Size for Test Set: Not applicable. No clinical test set data was presented in this 510(k) submission for the modified device.
• Data Provenance: Not applicable. No clinical testing or data from human subjects was provided for this specific device modification.

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

• Not applicable. No clinical ground truth was established through expert evaluation for a test set, as no clinical testing was performed for the modified device.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: None provided." (Section {1})

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

• Not applicable. This device is a physical medical implant (a femoral component for knee replacement), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The "standalone performance" here refers to the device's physical and mechanical performance, which was assessed through engineering analysis.

7. The Type of Ground Truth Used:

• The "ground truth" for the modified device was based on engineering analysis (Section {1}: "Engineering analysis was provided to demonstrate that the design change would not compromise the strength of the component.") and the established safety and effectiveness of the predicate device. The FDA's substantial equivalence determination implies that the existing clinical evidence and safety profile of the original Ascent™ Interlok® Femur serve as the "ground truth" for the narrower version, given that the changes are minor and assessed as not impacting core performance.

8. The Sample Size for the Training Set:

• Not applicable. The device is a physical implant. The concept of a "training set" typically applies to machine learning algorithms. In a manufacturing context, a "training set" might loosely refer to the historical data and experience gained from manufacturing the predicate device, but it is not explicitly mentioned or quantified in this submission.

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

• Not applicable due to the device type.

In summary, the clearance of the Narrow Ascent™ Interlok® Femoral Components was based on a demonstration of substantial equivalence to a legally marketed predicate device (Ascent™ Primary Interlok® Femur, K982869) through engineering analysis of the design change, rather than direct clinical testing of the modified device.

Summary

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K024037

BIOMET

Page 1 of 2

Summary of Safety and Effectiveness

Applicant/Sponsor:Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

DEC 3 0 2002

• Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist Telephone: [phone] Fax: [phone]
  Proprietary Name: Narrow Ascent™ Interlok® Femoral Components

Common Name: Knee replacement femoral component

Classification Name: Knee joint patello-femorotibial polymer/metal/polymer semiconstrained cemented prosthesis (21 CFR 888.3560)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Ascent™ Primary Interlok® Femur previously cleared in 510(k) K982869.

Device Description: The Narrow Ascent™ Interlok® Femoral Components are primary femoral components intended for use with an Ascent™ tibial component and patella for total knee replacement. The device is manufactured from cast cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75 with Biomet's Interlok®, 30 grit blasted finish. Three sizes, x-small, small, and medium are available in left and right configurations.

The device varies from the predicated device in that the width of the component in the medial-lateral direction has been reduced by approximately 4mm. This has been accomplished by reducing the width of each condyle by approximately 2mm. All other dimensions remain the same. A narrower femoral component is desired to avoid overhang of the device in a patient with a naturally narrow femur.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46587

OFFICE 574.267.6639

I·AX 574.267.8137

E-MAIL [e-mail]

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Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K od 24037", and the text at the bottom reads "page 2 of 2". The handwriting is somewhat messy, but the text is still legible.

Intended Use:

• 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• 2. Correction of varus, valgus, or posttraumatic deformity.
• 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure.

Summary of Technologies: The materials, design and processing of the modified device are identical to or similar to the predicate.

Non-Clinical Testing: Engineering analysis was provided to demonstrate that the design change would not compromise the strength of the component.

Clinical Testing: None provided.

Ascent and Interlok are trademarks of Biomet, Inc. Tyvek is a trademark of E.I. duPont de Nemours and Company

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 :

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K024037

Trade/Device Name: Narrow Ascent™ Interlok® Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II

Product Code: JWH Dated: December 5, 2002 Received: December 6. 2002

Dear Ms. Beres:

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 vour 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. Patricia Sandborn Beres

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html .

,一

Sincerely yours,

Madel - 11 Maden -

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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K024057 510(k) Number (if known):

Device Name: Name: Narrow Ascent™ Interlok® Femoral Components

Indications For Use: -

• 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• 2. Correction of varus, valgus, or posttraumatic deformity.
• 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure.

The device is indicated for implantation with cement.

Mad. J. Walker

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

510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

0000000

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.