Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases.
Fractures or vascular necroses.
Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty of total hip prosthesis (THP).

Device Description

The MS-30 is a highly polished metallic femoral component manufactured from forged stainless steel alloy (Protasul S30, ISO 5832-9). It is available in six sizes. The stem features a three dimensional conical wedge shape with rounded edges to aid in rotational stability, self centering in the femoral canal, and creation of a favorable cement mantle. The proximal aspect of the stem has a male 12/14 type morse taper for attachment of a Sulzer Orthopedics metallic or ceramic femoral The most distal aspect of the stem has a small pilot hole for attachment of a distal head. centralizer. The stem is intended for cemented use only.

The MS-30 also features an optional distal centralizer which is manufactured from PMMA (ISO 5833-1) with a wrought CoCr alloy locating pin (Protasul 10, ISO 5832-6). The pin provides for slip fit connection to the distal stem. The centralizer is conically shaped with a small proximal tab that prevents rotation about the stem upon insertion into the canal.

AI/ML Overview

This document is a 510(k) Summary for the Sulzer Orthopedics MS-30 Femoral Stem, a medical device for hip replacement, and does not contain the type of information requested regarding acceptance criteria and a study proving device performance.

The provided text focuses on:

Product Description: Materials, design, and sizes of the femoral stem and optional distal centralizer.
Specific Diagnostic Indications: Conditions for which the device is intended.
Substantial Equivalence: Comparison to other commercially available devices and a general statement that "Testing/analysis indicated that the device would survive physiologic loading."

It does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Details on experts for ground truth establishment.
Adjudication methods.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
Results from standalone performance studies.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This document is primarily for regulatory submission to demonstrate substantial equivalence to previously cleared devices, rather than a detailed performance study report.

Summary

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DEC - 2 1999

510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics MS-30 Femoral Stem.

Manufacturer:	Sulzer Orthopedics Ltd.Grabenstrasse 25CH 6341 Baar, Switzerland
US Designated Agent:	Sulzer Orthopedics Inc.9900 Spectrum DriveAustin, Texas 78717(512) 432-9900
Date:	September 7, 1999
Contact Person:	Mitchell A. Dhority, RACManager, Regulatory and Clinical Affairs
Classification Name:	21 CFR Part 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Common/Usual Name:	Cemented Femoral Stem Component
Trade/Proprietary Name:	Sulzer Orthopedics MS-30 Femoral Stem

PRODUCT DESCRIPTION

Femoral Stem

Distal Centralizer

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SPECIFIC DIAGNOSTIC INDICATIONS

The MS-30 Femoral Stem is intended for cemented use in treatment of the following:

Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases. 1.
1. Fractures or vascular necroses.
Status following earlier operations, such as joint reconstruction (osteotomy), 3. arthrodesis, hemiarthroplasty of total hip prosthesis (THP).

SUBSTANTIAL EQUIVALENCE

The MS-30 Femoral Stem is similar to the following commercially available devices in terms of intended use, materials and general design:

DePuy Endurance Polished Stem .
Howmedica Osteonics Exeter Hip Stem .
Zimmer VerSys Cemented CT Hip Stem .
Zimmer VerSys Heritage Hip Stem .

Testing/analysis indicated that the device would survive physiologic loading.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring three horizontal lines that curve and taper to a point on the right side.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Mitchell A. Dhority, RAC Mitcherr A. Bhorery, and Clinical Affairs SulzerMedica Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717

K993043 Re: APR Metasul Acetabular Insert Trade Name: Regulatory Class: II Product Code: LZO September 9, 1999 Dated: Received: September 10, 1999

Dear Mr. Dhority:

We have reviewed your Section 510(k) notification of intent to we have teviewed jeferenced above and we have determined the market the abrisotially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate ase beated in the enough, 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 The general controls provisions of the Act 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. ਬੇ 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 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 requlation may result in regulatory 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 regulations.

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Page 2 - Mitchell A. Dhority, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acobing of substantial equivalence of your device to a legally rinding of Subbeaneral Oquresults in a classification for your markets and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (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 Also, please note the Office of Compliance at (301) 594-4639. 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 obtained from eno more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III

Actinq Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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193043 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MS-30 Femoral Stem

Indications for Use:

The MS-30 Femoral Stem is intended for cemented use in treatment of the following:

Advanced wear of the joint due to degenerative, posttraumatic or rheumatic 1. diseases.
1. Fractures or vascular necroses.
Status following earlier operations, such as joint reconstruction (osteotomy), 3. arthrodesis, hemiarthroplasty of total hip prosthesis (THP).

NRo for
(Division Sign-Off)
Division of General Restorative Devices K993043
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 × OR

Over-the Counter Use _________________________________________________________________________________________________________________________________________________________

(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.