The subject hip stems are single-use devices intended for use in total hip replacement. They are designed for cementless fixation. They are intended for mechanical assembly to mating Howmedica V40™ Femoral Heads (excluding size +16mm (XX Long) V40 Femoral Heads).

Indications:
The indications for use of total hip replacement prostheses include:

Osteoarthritis and avascular necrosis,
Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or devices have failed, and
Revision procedures where other treatments or devices have failed, including neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

The subject devices are single-use components intended for cementless fixation within the prepared canals of patients requiring hip arthroplasty. Unlike the predicate devices, however, the subject devices feature a V40™ Taper, and are therefore intended only for assembly to mating, commercially available Howmedica V40™ Femoral Heads. Note, also, that the subject hip stems are not recommended for use with size +16mm V40TM Femoral Heads.

AI/ML Overview

The provided document describes a Special 510(k) for modifications to existing hip stems, focusing on the "Super Secur-Fit™ HA Hip Stems and Super Secur-Fit™ Plus HA Hip Stems." This type of submission is a declaration of substantial equivalence to a predicate device, based on the principle that the modifications do not raise new questions of safety or effectiveness. As such, it primarily relies on performance testing to demonstrate that the modified device is as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Metric	Reported Device Performance	Comments
Fatigue Strength (Neck Fatigue)	Testing performed in accordance with ISO 7206-6. Results are implicitly considered acceptable as the device received 510(k) clearance.	The document does not provide specific numerical values for the fatigue strength. It only states that testing was performed "in accordance with ISO 7206-6." For a 510(k) submission, the explicit acceptance criterion would typically be meeting or exceeding the fatigue strength of the predicate device, or demonstrating compliance with the standard's requirements for the intended load cycles. The positive 510(k) clearance implies that these criteria were met.
Material Compatibility (Implied)	The modification involves changing the C-Taper to a V40™ Taper and trimming the neck diameter. The device is intended for assembly with "mating, commercially available Howmedica V40™ Femoral Heads."	This implies compatibility with existing V40™ femoral heads, suggesting that material compatibility and mechanical fit were assessed and found acceptable to prevent issues like fretting corrosion or inadequate connection.

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

Sample Size: Not explicitly stated. For mechanical testing like fatigue, the sample size is typically determined by relevant ISO standards (e.g., ISO 7206-6) and statistical power analysis to demonstrate reliability.
Data Provenance: Not explicitly stated, but assumed to be prospective laboratory testing conducted by Howmedica Osteonics Corp. within the context of their device development and regulatory submission. The country of origin would likely be the USA, where Howmedica Osteonics Corp. is based.

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

Not Applicable. This submission is for mechanical device modifications, not an AI/Software as a Medical Device (SaMD) that relies on expert interpretation of output. The "ground truth" for mechanical performance is established through physical testing and adherence to engineering specifications and international standards (like ISO 7206-6).

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation of data, typically in AI/SaMD performance evaluations. For mechanical testing, the "adjudication" is inherent in the objective measurement and interpretation of physical test results against predetermined criteria set by industry standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. MRMC studies are specific to evaluating the impact of AI on human reader performance, common in diagnostic imaging. This submission deals with mechanical modifications to a hip stem.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not Applicable. This is a hardware modification, not an algorithm or software. The "standalone performance" is the mechanical performance of the hip stem itself under simulated physiological conditions.

7. The Type of Ground Truth Used:

Engineering Standards and Predicate Device Performance. The ground truth for this mechanical device is established by:
- ISO 7206-6 Standard: This international standard defines the methods for fatigue testing of femoral components with a prosthesis head and neck. Compliance with this standard ensures the device meets recognized performance benchmarks for durability.
- Predicate Device Performance: The underlying assumption of a 510(k) Special is that the modified device performs at least as well as the legally marketed predicate device (Secur-Fit™ HA Hip Stems and Secur-Fit™ Plus HA Hip Stems) in terms of safety and effectiveness, including mechanical strength. The new modifications (V40™ Taper, trimmed neck, modular collar slot) would have been tested to ensure they did not degrade performance.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" as this is not an AI/Machine Learning device.

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

Not Applicable. Since there is no training set, this question is not relevant.

In summary:

This 510(k) submission for mechanical hip stem modifications relies entirely on demonstrating that the revised design maintains the safety and effectiveness profile of its predicate device, primarily through physical performance testing (specifically neck fatigue testing per ISO 7206-6). The acceptance criteria are implicitly met by demonstrating compliance with this standard and showing that the new design performs comparably to the predicate, which is a fundamental requirement for 510(k) clearance. The document, typical for a Special 510(k) of this nature, describes the modifications and references the standard used for testing without delving into specific numerical test results, which would be contained in a more detailed technical report.

Summary

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MAY 1 3 2002

K010615

Modification to Secur-Fit™ HA Hip Stems and Secur-Fit™ Plus HA Hip Stems

Special 510(k) Summary:

Proprietary Name:	Super Secur-Fit™ HA Hip Stems and Super Secur-Fit™ Plus HA Hip Stems
Common Name :	Artificial Hip Components
Classification Name and Reference:	Hip joint, metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis, 21CFR §888.3353
Proposed Regulatory Class :	Class II
Device Product Code :	87 MEH
For Information contact:	Jennifer DaudelinHowmedica Osteonics Corp.59 Route 17Allendale, New Jersey 07401Phone: (201) 831-5379Fax: (201) 760-8435

Description/Technological Comparison

Predicate Device Name/Catalog# Series	Subject Modifications	Resulting Subject DeviceName/Catalog # Series
Secur-Fit™ HA Hip Stems (6051Aseries), 132° neck angle	• Change C-Taper to V40™ Taper• Trim neck diameter• Add slot for modular collar	Super Secur-Fit™ HA HipStems (J6051 series)
Secur-Fit™ HA Hip Stems (6052Aseries), 127° neck angle	• Change C-Taper to V40™ Taper• Trim neck diameter	Super Secur-Fit™ HA HipStems (J6052 series)
Secur-Fit™ Plus HA Hip Stems(6054A series), 127° neck angle	• Change C-Taper to V40™ Taper• Trim neck diameter	Super Secur-Fit™ Plus HAHip Stems (J6054 series)

Intended Use

The intended use of the modified hip stems remains essentially unchanged from that of the predicate hip stems. Like the predicate devices, the subject devices are single-use components intended for cementless fixation within the prepared canals of patients requiring hip arthroplasty. Unlike the predicate devices, however, the subject devices feature a V40™ Taper, and are

Special 510(k)

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Pge 2 of 2

Modification to Secur-Fit™ HA Hip Stems and Secur-Fit™ Plus HA Hip Stems

Special 510(k)

therefore intended only for assembly to mating, commercially available Howmedica V40™ Femoral Heads. Note, also, that the subject hip stems are not recommended for use with size +16mm V40TM Femoral Heads.

Testing Summary

Neck fatigue testing was performed in accordance with ISO 7206-6.

Page 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2002

Ms. Jennifer A. Daudelin Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401

Re: K020615

Trade/Device Name: Modification to Secur-Fit" HA and Secur-Fit" Plus HA Hip Stems Regulation Number: 21 CFR 888.3353

Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: Class II Product Code: MEH Dated: April 22, 2002 Received: April 23, 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 (OS) 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 proficated 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.

Mark N Millan

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

Enclosure

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620615 510(k) Number (if known): _

Device Name: Modification to Secur-Fit™ HA Hip Stems and Secur-FirM Plus HA Hip Stems (Super Secur-Fit™ HA Hip Stems and Super Secur-Fit™ Plus HA Hip Stems)

Indications:

The indications for use of total hip replacement prostheses include:

e indications for ass of total inp repartises including osteoarthritis and avascular necrosis, ●
Rheumatoid arthritis, �
Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, and .
Revision procountes where outler areasing neck and trochanteric fractures of the proximal femur . with head involvement that are 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)

Prescription Use

Over-The-Counter Use /No (Per 21 CFR 801.109)
(Optional Format 1-2-96)

for Mark n Milhersen

Sion Sign-( Division of General. Restorative and Neurological revices

510(k) Number K020615

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.