These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

Device Description

The V40™ femoral head components are fabricated from cobalt chromium alloy conforming to ASTM F799. These devices have an outer diameter range from 22mm to 32mm with varying neck offsets. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

AI/ML Overview

The provided text is a 510(k) summary for the LFIT™ V40™ Femoral Head Components, which are hip joint prosthetic components. This document does NOT describe the acceptance criteria and a study that proves a device meets those criteria. Instead, it details:

Device Identification: Proprietary name, common name, classification, product code.
Contact Information: For the manufacturer's regulatory affairs.
Purpose of Submission: To add V40™ femoral head components to an existing product series, asserting their substantial equivalence to predicate devices.
Predicate Devices: Identification of previously cleared devices and their characteristics (materials, dimensions).
Correspondence from FDA: An FDA letter confirming substantial equivalence and providing guidance on regulatory compliance.
Intended Use Statement: Describes the application of the device as modular components in primary or revision total hip arthroplasty.

Given that the document is a 510(k) summary for a hip implant and not a study report, it does not contain the information required to answer your prompt. There are no performance metrics, study designs, sample sizes, expert qualifications, or ground truth details presented here. The submission is based on substantial equivalence to existing devices, meaning its safety and effectiveness are inferred from the predicate devices, rather than through a new, specific performance study with acceptance criteria.

Summary

{0}------------------------------------------------

APR 1 1 2001

010757

Special 510(k) Summary - Addition of V40™ Femoral Head Components to the Ion Implanted Femoral Bearing Series

Proprietary Name:

Common Name:

LFITTM V40TM Femoral Head Components

Femoral Head Component

Classification Name and Reference:

21 CFR 888.3350 Hip Joint Metal/ Polymer Semi-constrained Cemented Prosthe

Proposed Regulatory Class:

Device Product Code:

For Information contact:

(87) JDI, LWJ, KWY

Jennifer A. Daudelin, Regulatory Affairs Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 (201) 934-4354 Fax: (201) 760-8435 Email: jdaudelin@howost.com

This Special 510(k) submission is intended to add the V40™ femoral head components to the Ion Implanted 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 ion implanted femoral bearing components were found substantially equivalent via the 510(k) process in K910988. The V40™ femoral head components were cleared in 510(k) numbers: K936126, K950541, and K993601. The predicate ion implanted devices are cobalt chromium alloy femoral heads conforming to ASTM F1537. The V40TM fernoral head components are also fabricated from cobalt chromium alloy conforming to ASTM F799. These devices have an outer diameter range from 22mm to 32mm with varying neck offsets. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

{1}------------------------------------------------

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or abstract human figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2001

Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K010757

Trade Name: LFIT™ V40™ Femoral Heads Regulatory Class: II Product Code: JDI, LWJ, and KWY Regulation: 21 CFR 888.3350 Dated: March 12, 2001 Received: March 13, 2001

Dear Ms. Daudelin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

{2}------------------------------------------------

Page 2 - Ms. Jennifer A. Daudelin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Mark N Melhusen

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

{3}------------------------------------------------

Indications for Use

510(k) Number (if known): K010757

Device Name: LFITTM V40TM Femoral Heads

Indications for Use:

These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Murle N. Millkus

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

510(k) Number K010757

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.