The Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include:

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-union, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

Device Description

The currently marketed Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems were revised to incorporate a streamlined neck geometry and modify the C-Taper trunnion length.

AI/ML Overview

This 510(k) summary describes a modification to existing hip stems, not a new AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific parameters (like sample size for test sets, ground truth establishment, MRMC studies, etc.) is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence of the modified hip stems to their predicate devices based on design similarities and mechanical testing.

Here's a summary of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't present specific quantitative acceptance criteria or a "reported device performance" in the way one would for an AI/ML diagnostic device with metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implicitly met by demonstrating that the modified stems maintain similar neck strength as the predicate devices.

The study presented is a comparison to predicate devices, not a performance study against a predefined clinical metric.

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

Sample Size: Not explicitly stated as this is not an AI/ML clinical study. The "test set" here would refer to the mechanical tests performed. These typically involve a small number of carefully manufactured prototypes.
Data Provenance: Not applicable in the context of clinical data provenance. The "data" originated from mechanical testing performed on the modified hip stems.

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

Not applicable. "Ground truth" in this context would be established by engineering specifications and objective mechanical testing results, not expert interpretation of retrospective clinical data.

4. Adjudication Method for the Test Set:

Not applicable. Mechanical testing results are objective measurements, not subject to expert adjudication.

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. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used:

Mechanical testing results and engineering specifications demonstrated that the modified stems have similar neck strength to the predicate devices. The "ground truth" is based on the physical properties and performance of the device under testing.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.

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

Not applicable.

In summary, the provided text describes a modification to an existing medical device (hip stems) and focuses on demonstrating substantial equivalence to predicate devices through design comparison and mechanical testing, not through clinical performance evaluation of an AI/ML system.

Summary

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K041170

Traditional 510(k) Summary of Safety and Effectiveness for the MODIFICATION TO SECUR-FIT™ HA AND SECUR-FIT™ PLUS HIP STEMS

Proprietary Name:	Secur-Fit™ HA and Secur-Fit™ Plus Hip
Stems
Common Name:	Artificial Hip Components
Classification Name and Reference	Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prostheses,
	21 CFR §888.3353
Regulatory Class:	Class II
Device Product Code:	87 MEH, 87 LZO
For Information contact:	Karen Ariemma
	Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	325 Corporate Drive
	Mahwah, New Jersey 07430
	Phone: (201) 831-5718
	Fax: (201) 831-6038E-Mail: karen.ariemma@stryker.com

Date Summary Prepared:

November 4, 2004

Device Description

The currently marketed Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems were revised to incorporate a streamlined neck geometry and modify the C-Taper trunnion length.

Intended Use:

Indications for Use

The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include:

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-union, femoral neck and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.

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Substantial Equivalence:

The features of the modified stems are substantially equivalent to the corresponding features of the predicate Osteonics Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems determined substantially equivalent via 510(k)s K941366, K951517, 982032, K990203, and K020615. The modified stems are similar to the predicate stems in every aspect with the exception of the streamlined neck geometry and the modified C-Taper trunnion The testing used to evaluate the subject stems demonstrates substantial length. equivalence of the modified device to the predicate device in regards to neck strength. In addition, the intended use, material, manufacturing methods, packaging, package insert, and sterilization of the modified and unmodified stems are identical.

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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 is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring three figures or lines above a wavy base, representing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2004

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. New Jersey 07430

Re: K041170

Trade/Device Name: Modification to Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO, MEH Dated: October 15, 2004 Received: October 21, 2004

Dear Ms. Ariemma:

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

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Page 2 - Karen Ariemma

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. 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/dsma/dsmamain.html

Sincerely yours,

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

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __K041170

Device Name: Modification to SECUR-FIT™ HA and SECUR-FIT™ PLUS Hip Stems

Indications For Use:

The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include:

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-union, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark
(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number K041170

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.