noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
rheumatoid arthritis,
correction of functional deformity,
revision procedures where other treatments or devices have failed, and
treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Device Description

The Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head is composed of magnesia partially stabilized zirconia (MG-PSZ). The head is generally spherical with a Whiteside Biomechanics, Inc. 12/14 bore machined from distal to proximal. Around the base of the bore a flat will be machined and will be laser-engraved for labeling purposes.

AI/ML Overview

The provided text is a 510(k) summary for the Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head, and it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.

The document primarily covers:

Device Identification: Classification name, number, common name, proprietary name, and manufacturer details.
Device Description: Material composition (magnesia partially stabilized zirconia), spherical shape, and bore specifications.
Intended Use: Five specific indications for use in hip replacement procedures.
Additional Information: Material composition reiteration, sterilization method (ETO with nitrogen), and labeling for sterilization indicators.
FDA Communication: A letter from the FDA confirming substantial equivalence to pre-amendment devices, outlining regulatory class (II) and product code (LZO), and specifying a limitation regarding use with titanium alloy hip stems with Whiteside Biomechanics, Inc. 12/14 taper trunnions.
Indications for Use Form: A summary of the intended uses.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this data is not present in the provided document.

This type of 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria, sample sizes, ground truth establishment, or specific expert involvement for a standalone or MRMC study. Typically, such studies would be included in the full 510(k) submission, not necessarily in the publicly available summary.

Summary

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K973261

510(k) SUMMARY

87LZO

femoral head

NOV 2 4 1997

Device:

Classification Name:

Prosthesis, Hip, Semi-constrained, Metal /Ceramic/Polymer, Cemented or Non-porous Uncemented

Classification No .: Common / Usual Name:

Proprietary Name:

Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head

Manufacturer Identification:

Whiteside Biomechanics, Inc. 12634 Olive Blvd. St. Louis, MO 63141

Establishment Registration Number: 1932213

Device Description:

Intended Use:

This device is intended to be used for :

noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis,
1. rheumatoid arthritis,
1. correction of functional deformity,
revision procedures where other treatments or devices have failed, and 4.
treatment of non-unions, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement, unmanageable using other techniques.

Additional Information:

This femoral component is composed of magnesia partially stabilized zirconia (Mg-PSZ). This device will be supplied double pouched and sterilized by 100% ethylene oxide (ETO) with nitrogen. The outer and inner package labels will include a sterilization indicator that changes color with exposure to the sterilant.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three intertwined strands resembling a double helix, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is positioned to encircle the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 24 1997

Mr. Michael C. Wall Official Correspondent Whiteside Biomechanics, Inc. 12634 Olive Boulevard St. Louis, Missouri 63141

K973261 Re : Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head Regulatory Class: II Product Code: LZO August 25, 1997 Dated: Received: August 29, 1997

Dear Mr. Wall:

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 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 qeneral controls provisions of the Act and the following limitation that the package insert must reflect that the Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Heads are to be used only with titanium alloy (Ti6Al4V) hip stems with the Whiteside Biomechanics, Inc. 12/14 taper trunnions.

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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug

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Page 2 - Mr. Michael C. Wall

Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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 Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K973261_

Device Name: CERAMIC UNIPOLAR FEMORAL HEAD

Noninflammatory degenerative joint disease, Indications For Use: 1. including osteoarthritis and avascular necrosis.

Rheumatoid arthritis 2.
1. Correction of functional deformity
Revision procedures where other treatments 4 . or devices have failed.
Treatment of non-unions, femoral neck, and 5. trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices, & 73211

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

510(k) Number.

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.