The ULTIMA* TPS Cemented Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to:

structural damage in the hip joint from rheumatoid arthritis,
osteoarthritis,
post-traumatic arthritis,
collagen disorders,
avascular necrosis,
nonunion of femoral fractures,
congenital hip dysplasia,
protrusio acetabuli,
slipped capital femoral epiphysis, and
disability due to previous fusion where bone stock is inadequate for other reconstruction techniques.
The ULTIMA* TPS Cemented Stem is indicated for use only with PMMA bone cement.

Device Description

The ULTIMA* TPS Cemented Stem is forged from a Cobalt-Chromium alloy which conforms to ASTM F799 (EXHIBIT IV); this material has high strength and good hardness properties and is also highly immune to fatigue. The ULTIMA* TPS Cemented Stem is polished to a bright finish on all surfaces below the spigot and can be used interchangeably in either the left or the right hip. The stem is straight, tapering towards the distal tip in both the mediolateral and anteriorposterior sections. It does not have a proximal collar.
The ULTIMA* TPS Cemented Stem has a 10/12 Morse taper; it will be available in six sizes (0, 1 - 5), each of the 1 - 5 sizes have a choice of either a 37.5 mm (standard) offset, or a 44.0 mm (medialized "M") offset. In addition to this central range, there shall be two long stern options. The stem can be used with various neck heads (22.225, 26, 28 and 32 mm) as well as neck options (-5 (32), -3 (28), 0, +5 and +10). All of the stems in the range have a neck angle of 125°.
The distal centralizer that is used with the ULTIMA* TPS stem comes in a range of sizes and is manufactured from PMMA. There are three wings on the centralizer which ensure the orientation of the stem distally. These increase in size through the centralizer range to deal with the variation in anatomy of the medullary canal. In revision surgery, a "wingless" centralizer is required, thus a 7mm diameter version is available which simply acts to provide the void, and does not centralize the stem.

AI/ML Overview

The provided text describes the ULTIMA* TPS Cemented Stem, a hip joint prosthesis, and focuses on its substantial equivalence to predicate devices, rather than a study proving new performance criteria through clinical trials. Therefore, much of the requested information regarding acceptance criteria specific to a performance study, sample sizes, expert adjudication, MRMC studies, or multi-reader multi-case comparative effectiveness studies cannot be extracted directly from this document.

The document primarily establishes "substantial equivalence" based on design, materials, intended use, and mechanical testing results.

Here's the information that can be extracted or inferred based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (ULTIMA* TPS Cemented Stem)
Substantial Equivalence (Functional)	Functionally equivalent to Howmedica Exeter hip stem (#K891454) and Zimmer CPT hip stem.	Stated to be substantially equivalent.
Mechanical Performance	Withstand a maximum load of 2,300N force.	Meets this criterion.
Mechanical Performance	Withstand 5,000,000 cycles.	Meets this criterion.
Material Conformance	Material conforms to ASTM F799 (Cobalt-Chromium alloy).	Forged from a Cobalt-Chromium alloy which conforms to ASTM F799.

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

The document does not detail specific sample sizes for mechanical testing. It mentions "testing results" indicating the device meets the criteria, which implies that mechanical tests were conducted on an unspecified number of device samples.

Sample Size for Test Set: Not specified for mechanical testing.
Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Johnson & Johnson Professional, Inc. (the manufacturer). This is a pre-market notification (510(k)) and not a clinical trial; therefore, there is no patient data provenance in this context.

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

Not applicable. This document describes mechanical testing for substantial equivalence, not a study requiring expert clinical assessment for ground truth. The "ground truth" for mechanical properties is established by engineering standards (e.g., ASTM F799) and the specified thresholds (e.g., 2,300N force, 5,000,000 cycles).

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions.

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

No. This document does not describe an MRMC comparative effectiveness study. It focuses on demonstrating substantial equivalence based on design, materials, and mechanical properties against predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in the context of mechanical testing. The "performance" being assessed here is the device's physical response to specified forces and cycles, which is a standalone evaluation of the device itself (analogous to "algorithm only" in an AI context, but for a physical product).

7. The Type of Ground Truth Used

The ground truth used for this type of device's "performance" is based on:

Engineering standards (e.g., ASTM F799 for material properties).
Predefined mechanical thresholds (e.g., 2,300N force, 5,000,000 cycles) typically derived from industry acceptance or predicate device performance.
Comparison of design features and materials to predicate devices to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI study, so there is no concept of a "training set."

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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K965198

Summary of Safety & Effectiveness Data JUL 2 3 1997 for the ULTIMA* TPS Cemented Stem

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

1. Contact Person

Janet G. Johnson, Assoc. Regulatory Affairs Specialist, (508) 828-3466.

2. Device Name

Proprietary Name:	ULTIMA* TPS Cemented Stem
Common Name:	Hip joint metal/polymer semi-constrained cemented prosthesis
Classification Name:	Prosthesis, Hip
Regulatory Class:	Class II by 21 CFR § 888.3350
Product Code:	87JDI
Owner/ Operator #	9001269

3. Device Classification

Classification for ULTIMA* TPS Cemented Stem has been placed in Class II by 21 CFR & 888.3350

4. Statement of Substantial Equivalence

The safety and effectiveness of the ULTIMA* TPS Cemented Stem is substantially equivalent in terms of function to the Howmedica Exeter hip stem (#K891454) and to the Zimmer CPT hip stem. Furthermore, testing results demonstrate that the ULTIMA* TPS Cemented Stem is substantially equivalent by withstanding a maximum load of 2,300N force, 5,000,000 cycles, and, as such meets the set criteria for the establishment of "substantial equivalence".

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ર. Indications for Use

The ULTIMA* TPS Cemented Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to:

1. structural damage in the hip joint from rheumatoid arthritis,
1. osteoarthritis,
1. post-traumatic arthritis,
1. collagen disorders,
1. avascular necrosis,
1. nonunion of femoral fractures,
1. congenital hip dysplasia,
1. protrusio acetabuli,
1. slipped capital femoral epiphysis, and
1. disability due to previous fusion where bone stock is inadequate for other reconstruction techniques.

The ULTIMA* TPS Cemented stem is indicated for use only with PMMA bone cement.

6. Physical Description

The ULTIMA* TPS Cemented Stem has a 10/12 Morse taper; it will be available in six sizes (0, 1 - 5), each of the 1 - 5 sizes have a choice of either a 37.5 mm (standard) offset, or a 44.0 mm (medialized "M") offset. In addition to this central range, there shall be two long stern options. The stem can be used with various neck heads (22.225, 26, 28 and 32 mm) as well as neck options (-5 (32), -3 (28), 0, +5 and +10). All of the stems in the range have a neck angle of 125°.

Stem Size	TrunnionDesigns	Offset	NeckHeads	NeckOptions	NeckAngle
0,1,2,3,4,5	10/12 taper	37.5 /44.0mm	22.225,26, 28, 32mm	-5 (32),-3 (28),0, +5,+10	125°

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Distal The distal centralizer that is used with the ULTIMA* TPS stem Centralizer comes in a range of sizes and is manufactured from PMMA. There are three wings on the centralizer which ensure the orientation of the stem distally. These increase in size through the centralizer range to deal with the variation in anatomy of the medullary canal. In revision surgery, a "wingless" centralizer is required, thus a 7mm diameter version is available which simply acts to provide the void, and does not centralize the stem.

	ULTIMA* TPSCemented Stem	HowmedicaExeter hip stem	Zimmer CPT hipstem
DESIGN
Polished	Yes	Yes	Yes
Collarless	Yes	Yes	Yes
Double-tapergeometry	Yes	Yes	Yes

INTENDED USE
Total / partial hipreplacement	Yes	Yes	Yes
Used with distalcentralizer	Yes	Yes	Yes

MATERIALS
Orthinox™ (stainlesssteel alloy)	No	Yes	No
Zimtron™ (stainlesssteel alloy)	No	No	Yes
Cobalt-Chromium-Molybdenum	Yes	No	No

Table 1. Similarities and Differences Matrix

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, symbolizing service to the nation. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet G. Johnson Associate Regulatory Affairs Specialist Johnson & Johnson Professional, Iñc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

JUL 2 3 1997

Re: K965198 Ultima* TPS Cemented Stem Regulatory Class: II Product Codes: JDI and KWL Dated: April 22, 1997 Received: April 25, 1997

Dear Ms. Johnson:

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 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 Requlations, 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 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. I Failure to comply with the GMP regulation may result in requlatory 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 requlations.

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Page 2 - Ms. Janet G. Johnson

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 leqally 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 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.qov/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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Indications for Use for the ULTIMA* TPS Cemented Stem

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Indications for Use K965198

The ULTIMA* TPS Cemented Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to:

structural damage in the hip joint from rheumatoid arthritis, 1.
1. osteoarthritis,
post-traumatic arthritis, 3.
1. collagen disorders,
ડ. avascular necrosis,
Q. nonunion of femoral fractures,
1. congenital hip dysplasia.
1. protrusio acetabuli,
1. slipped capital femoral epiphysis, and
1. disability due to previous fusion where bone stock is inadequate for other reconstruction techniques.

The ULTIMA* TPS Cemented Stem is indicated for use only with PMMA bone cement.

Prescription Use
(Per 21 CFR 801.109)

Director Sign Off

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.