(29 days)
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.
This Special 510(k) submission is intended to add 36mm V40™ femoral head components in -5mm, +0mm, +5mm and +10mm offsets to the LFIT™ and non-LFFTTM Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The V40™ femoral head components are fabricated from Cobalt Chromium Alloy conforming to ASTM F1537. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
The provided text is a 510(k) summary for a medical device (femoral head components) and does not describe a study involving acceptance criteria for an AI/algorithm-driven device. It is a regulatory submission for a physical hip implant component. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information is not applicable to this document.
The document indicates that the 36mm V40™ Femoral Head Components are being added to existing product lines (LFIT™ and non-LFIT™ Series) and asserts that the "intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices." The regulatory process relies on demonstrating substantial equivalence to these predicate devices.
Summary of Device and Predicate:
| Attribute | Subject Device | Predicate Device |
|---|---|---|
| Proprietary Name: | 36mm V40™ Femoral Head Components (LFIT™ and Non-LFIT™) | 22mm-32mm V40™ Femoral Head Components (LFIT™ and Non-LFIT™) |
| Common Name: | Femoral Head Component | Femoral Head Component |
| Classification Name & Reference: | 21 CFR §888.3350 Hip Joint Metal/Polymer Semi-Restrained Cemented Prosthesis | 21 CFR §888.3350 Hip Joint Metal/Polymer Semi-Restrained Cemented Prosthesis |
| Proposed Regulatory Class: | II | II |
| Device Product Code: | (87) JDI, LWJ, KWY | (87) JDI, LWJ, KWY |
| Intended Use: | Modular components of a total hip system; intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty. | Modular components of a total hip system; intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty. (Implied, as subject device is "identical") |
| Materials: | Cobalt Chromium Alloy conforming to ASTM F1537 | Cobalt Chromium Alloy conforming to ASTM F1537 (Implied, as subject device is "identical") |
The core of this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices, by showing that the new 36mm size head, despite being larger, shares the same fundamental characteristics, materials, and intended use as the smaller cleared predicate devices. There is no performance study described in the context of acceptance criteria for an AI or algorithm.
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JUL 2 5 2002 -
Special 510(k) Summary - Addition of 36mm V40™ Femoral Heads To The LFIT™ And Non-LFIT™ Series
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Proprietary Name: | 36mm V40TM Femoral HeadComponents (LFITTM and Non-LFITTM) | 22mm-32mm V40TM Femoral HeadComponents (LFITTM and Non-LFITTM) |
| 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: jdaudelin@howost.com | |
| Date Summary Prepared: | June 14. 2002 |
This Special 510(k) submission is intended to add 36mm V40™ femoral head components in -5mm, +0mm, +5mm and +10mm offsets to the LFIT™ and non-LFFTTM 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 LFIT™ V40™ femoral bearing components were found substantially equivalent via the 510(k) process in K010757. The non-LFIT™ V40™ femoral head components were cleared in 510(k) numbers: K936126, K950541, and K993601. The V40™ femoral head components are fabricated from Cobalt Chromium Alloy conforming to ASTM F1537. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, serif font. The words are arranged on a single line and centered.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
JUL 2 5 2002
Re: K022077
Trade/Device Name: 36mm V40™ Femoral Head Components (LFIT™ and Non-LFIT™) Regulation Number: 21 CFR 888.3350 and 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: June 25, 2002 Received: June 26, 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.
O Mark N Milliken
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): K022077
Device Name: 36mm V40™ 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.
R. Mark N. Milken
ion Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022077
(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)
§ 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.