PROXILOCK HIP PROSTHESIS; SIZE 12/36 by IMPLEX CORP.

The ProxiLock Hip Prosthesis is intended for use where severe degeneration of the hip joint is necessary due to osteoarthritis, rheumatoid arthritis, trauma, revision of previously failed total hip arthroplasty or other pathology.

Device Description

The ProxilLock Hip Prosthesis offers the surgeon a cementless option in reconstructing the hip joint on the femoral side. The stem is intended for use in the relatively younger, moderate and higher demand patient in hybrid or cementless hip arthroplasty. The Implex ProxiLock Hip Prosthesis is compatible with all Implex acetabular Hip components. The ProxiLock Hip Prosthesis is available in an array of sizes to fit a patient size range. The stem system is available without a distal slotted stem. The ProxiLock Stem is intended to be used as a cementless stem only, and is intended to cooperate with Implex Femoral Bearing Heads via a tapered locking mechanism between the neck of the ProxiLock Hip Prosthesis and the Modular Bearing Head. Implex Modular Bearing Heads are compatible with all Implex Femoral Stems.

AI/ML Overview

The provided 510(k) summary does not contain information about the acceptance criteria or a study proving the device meets specific acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or accuracy, and details about a test set, ground truth establishment, or expert involvement).

Instead, this document focuses on the substantial equivalence of the ProxiLock Hip Prosthesis to a predicate device based on mechanical testing and material changes.

Here's a breakdown of the information that is available, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Strength Criteria (implicitly, for mechanical properties)	Passed strength criteria (mechanical testing, similar to predicate device)
Fatigue Criteria (implicitly, for mechanical properties)	Passed fatigue criteria (mechanical testing)
Tolerances (implicitly, for mechanical properties)	Passed tolerance requirements (mechanical testing)
Sterility Testing	Test data provided in predicate submission; device presumably meets sterility standards.
Package Integrity	Test data provided in predicate submission; device presumably meets integrity standards.
HA Integrity in Saline	Test data provided in predicate submission; device presumably meets integrity standards.
Dissolution Characteristics of HA Coating	Test data provided in predicate submission; device presumably meets dissolution standards.
Modular Locking Head Test	Test data provided in predicate submission; device presumably meets locking standards.

Missing Information: The document does not specify quantitative acceptance criteria for "strength," "fatigue," or "tolerances" (e.g., "must withstand X N of force," or "fatigue life of Y cycles"). It only states that the device "passed the strength criteria" and that testing showed the manufacturing change "does not adversely influence the strength, fatigue, or tolerances."

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

Sample Size: Not specified. The document refers to "mechanical testing" and "test data" but does not give sample sizes for these tests.
Data Provenance: The tests are "conducted... in a manner similar to the predicate device." The location or nature of these tests (e.g., in-house, third-party lab) is not specified, nor is whether the data is retrospective or prospective.

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

Not applicable / Not specified. This type of information is relevant for studies involving human interpretation (e.g., medical imaging devices). For a mechanical device like a hip prosthesis, the "ground truth" for performance is typically established through engineering standards and validated physical testing methods, not expert clinical consensus in the way a diagnostic device would. No experts are mentioned in the context of establishing performance ground truth.

4. Adjudication Method for the Test Set

Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in tasks like image interpretation. This is not relevant for the mechanical testing described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a mechanical hip prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or analysis of human reader improvement with AI assistance is not relevant.

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

Not applicable. This device does not involve an algorithm. Mechanical testing was performed on the device itself.

7. The Type of Ground Truth Used

For the described performance, the "ground truth" would be established by engineering standards and validated mechanical testing protocols (e.g., ASTM standards for fatigue, strength, etc.). The document refers to "strength criteria," but the specific quantifiable metrics are not provided.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI models, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

In summary: The provided 510(k) emphasizes a comparison to a predicate device and mechanical testing to demonstrate substantial equivalence, rather than meeting specific, quantitatively defined acceptance criteria through a clinical study with human data interpretation. The evaluation framework used for this device is typical for a mechanical implant seeking 510(k) clearance, focusing on engineering performance and material properties.

Summary

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OCT 2 2002

K022966

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Hedrocel Vertebral Body Replacement System

Submitter NameAnd Address:	Implex Corp.80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person:	Marci Halevi
Phone Number:	(201) 818-1800
Fax Number:	(973) 829-0825
Date Prepared:	September 5, 2002
Device Trade Name:	ProxiLock Hip Prosthesis; size 12/36
Device Common Name:	Hip Stem
Classification Numberand Name:	21CFR888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Substantial The term "substantial equivalence" as used in this 510(k) Equivalence: notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

Device The ProxilLock Hip Prosthesis offers the surgeon a cementless option Description: in reconstructing the hip joint on the femoral side. The stem is intended for use in the relatively younger, moderate and higher demand patient in hybrid or cementless hip arthroplasty. The Implex ProxiLock Hip Prosthesis is compatible with all Implex acetabular Hip components. The ProxiLock Hip Prosthesis is available in an array of sizes to fit a patient size range. The stem system is available without a distal slotted stem. The ProxiLock Stem is intended to be used as a cementless stem only, and is intended to cooperate with Implex Femoral Bearing Heads via a tapered locking mechanism between the neck of the ProxiLock Hip Prosthesis and the Modular Bearing Head. Implex Modular Bearing Heads are compatible with all Implex Femoral Stems.

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510(k) Summary (Continued)

Indications for Use: The ProxiLock Hip Prosthesis is intended for use where severe degeneration of the hip joint is necessary due to osteoarthritis, rheumatoid arthritis, trauma, revision of previously failed total hip arthroplasty or other pathology. Device Technological The device is unique in comparison to predicates only in regard Characteristics and to the manufacturing process used for the raw material (ASTM Comparison to F136 Ti-6Al-4V), from plate to forged titanium alloy. Additionally, the predicate is available with and without a distal Predicate Device: slot, the current device is available only without a distal slot.
Performance Data: Mechanical testing was conducted (reference Appendix D) in a manner similar to the predicate device and passed the strength criteria. This testing showed that the change from plate to forged raw material does not adversely influence the strength, fatigue, or tolerances of the device.

Test data has been provided in the predicate submission regarding :

Fatique Testing ●
Sterility Testing ●
Package Integrity ●
Masterfile Reference for HA .
. HA Integrity in saline
. Dissolution Characteristics of HA Coating
. Modular Locking Head Test

Conclusion:

The Implex ProxiLock Hip Prosthesis is substantially equivalent to the following predicate devices identified in this premarket notification:

510(k) #	Product Name	Company
K935990	F-220 Femoral Press-Fit Hip Stem	Implex Corp.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures, possibly representing people or families, with flowing lines suggesting movement or connection.

OCT 0 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marci Halevi Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401

Re: K022966

Trade/Device Name: ProxiLock Hip Prosthesis size 12/36 HA Coated Titanium Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: LWJ Dated: September 5, 2002 Received: September 6, 2002

Dear Ms. Halevi:

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 Acc 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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Page 2 - Ms. Marci Halevi

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 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,

Celia M. Witten, Ph.D., M.D.

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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510(k) Number (if known) :

K022966

Device Name:

The ProxiLock Hip Prosthesis

Indications For Use:

Indications:

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescriptio y h n Use (Per 21 CFR 801.109)

OR . . .

Over-The-Counter Use

(Optional Format 1-2-96)

Mark H. McAvoy
(Division Sign Off)

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

510(k) Number .

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.