The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following:

Patient conditions of noninflammatory degenerative joint disease, e.g., avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g., rheumatoid arthritis;
Those patients with failed previous surgery where pain, deformity, or dysfunction persists; and
Revision of a previously failed hip arthroplasty.

Device Description

Both the BetaCone and the predicate Encore, CLS, and Alloclassic Hip Stems use titanium alloy straight, tapered stems to replace the femur in hip replacement procedures. The BetaCone is fabricated from Ti-6Al-4V titanium alloy. BetaCone stems are available in 9 standard and 9 XL sizes. with lengths ranging from 135 to 175 mm. The BetaCone stem has a rectangular cross-section slightly rounded in both planes. BetaCone XL neck lengths are 5 mm longer than standard stem neck lengths. The Beta Cone neck angle is 126°. A 12/14 taper connects with Link's prosthesis heads using the same size taper. The BetaCone is compatible with Link standard acetabular cups. The BetaCone stem is designed for uncemented, press-fit fixation. A proximal trochanter fin supports proximal press-fit fixation.

AI/ML Overview

The acceptance criteria and study proving the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Dynamic fatigue testing per ISO 7206-4:2002	No prosthesis failed up to 5 million cycles at a maximum load of 2.3kN.

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

Sample Size: Five samples of the same sized, worst-case stem were tested.
Data Provenance: The study appears to be a laboratory bench test, rather than a clinical study with patient data. Its provenance isn't explicitly stated as a country but is implied to be internal testing by the manufacturer, Waldemar Link GmbH & Co. KG (Germany).
Retrospective/Prospective: Not applicable, as this was a bench test.

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

Not applicable. This was a physical bench test to evaluate mechanical properties, not a study requiring expert clinical judgment or ground truth derived from expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This was a physical bench test; there was no human adjudication of results in the traditional sense of clinical studies. The failure or non-failure of the prosthesis in a dynamic fatigue test is an objective measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document describes a medical device (hip prosthesis) and a bench test for its mechanical integrity, not an AI-based diagnostic tool that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this bench test was the objective physical behavior of the prosthesis under specified dynamic fatigue conditions. The standard ISO 7206-4: 2002 defines the parameters and expected outcomes for qualifying a hip prosthesis for fatigue resistance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device and a bench test, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

Summary

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K051826

510(k) SUMMARY

Waldemar Link GmbH & Co. KG's BetaCone™ Hip Prosthesis System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Waldemar Link GmbH & Co. KG Barkhausenweg 10 D-22339 Hamburg Germany Telephone: 49 (0)40 5 39 95-0 49 (0)40 5 38 69 29 Fax:

Peter Keller Contact Person:

Date Prepared: July 5, 2005

Name of Device and Name/Address of Sponsor

BetaCone™ Hip Prosthesis System

Waldemar Link GmbH & Co. KG Barkhausenweg 10 D-22339 Hamburg Germany

Common or Usual Name

Femoral Hip Stem

Classification Name

Hip joint metal/polymer semi-constrained cemented prosthesis, 21 C.F.R. § 888.3350, JDI; Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, 21 C.F.R. § 888.3360, LWJ.

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Predicate Devices

Encore Orthopaedics' SL-Plus and SLR-Plus Stems (Encore) (K930963); Centerpulse's CLS Spotorno Stems (CLS) (K042249, K010839); Zimmer's Alloclassic Femoral Stems (Alloclassic) (K033664, K030373).

Intended Use / Indications for Use

The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following:

Patient conditions of noninflammatory degenerative joint disease, e.g., � avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g., rheumatoid arthritis;
Those patients with failed previous surgery where pain, deformity, or � dysfunction persists; and
Revision of a previously failed hip arthroplasty. .

Technological Characteristics and Substantial Equivalence

A 12/14 taper connects with Link's prosthesis heads using the same size taper. The BetaCone is compatible with Link standard acetabular cups.

The BetaCone stem is designed for uncemented, press-fit fixation. A proximal trochanter fin supports proximal press-fit fixation.

The BetaCone is substantially equivalent to the other currently marketed femoral hip stems which are referenced above. The BetaCone and its predicate devices have the same intended use and indications for use; all are titanium alloy, straight, tapered stems available in a similar range of sizes and employing the same essential design geometry. Thus, the BetaCone raises no new issues of safety or effectiveness.

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and the country of the count

・

Performance Data – Bench Testing

.......

The BetaCone prosthesis was subjected to dynamic fatigue testing in accordance with ISO 7206-4: 2002, using an 80mm potting level. Five samples of the same sized, worst case stem were tested. No prosthesis tested at a maximum load of 2.3kN failed up to 5 million cycles.

ੁ *

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Public Health Service

Image /page/3/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol.

NOV 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Waldemar Link GmbH & Co. KG c/o Janice M. Hogan, Partner Hogan & Hartson L.L.P. 1835 Market Street, 28th Floor Philadelphia, Pennsylvania 19103

Re: K051826

Trade/Device Name: BetaCone™ Hip Prosthesis System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: LWJ, JDI Dated: November 2, 2005 Received: November 2, 2005

Dear Ms. Hogan:

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. Iisting 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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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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,
Mark A. Milken

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_ K05-1826

Device Name: BetaCone™ Hip Prosthesis System

Indications for Use:

The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following:

Patient conditions of noninflammatory degenerative joint disease, e.g., . avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g.,
The unstailers the its it is it inflammatory joint disease, e.g., rheumatoid arthritis;
Those patients with failed previous surgery where pain, deformity, or ● dysfunction persists; and
Revision of a previously failed hip arthroplasty. .

Mark A. Molkerson

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

510(k) Number

K051826

4 5 2.3 18

Prescription Use _ V (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

PH - 67488/0006 - 19265

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.