The ActiveLock Modular Femoral Hip System is intended for primary or revision reconstruction, with or without bone cement, of the femoral portion of severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:

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 nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Device Description

The ActiveLock M Modular Femoral Hip System is a matrix of interchangeable components (STEM, BODY, ACTUATOR, FEMORAL HEAD) that can be locked together to form a single femoral hip prosthesis.

AI/ML Overview

The provided text is a 510(k) summary for the ActiveLock™ Modular Femoral Hip System, which is a medical device for hip replacement. It outlines the device's design, materials, and substantial equivalence to previously marketed devices. However, this document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of clinical effectiveness or diagnostic accuracy.

The document focuses on:

Substantial Equivalence: Comparing the new device's design, materials, and intended use to existing devices (predicates). This is a regulatory pathway for approval, not a clinical performance study.
Mechanical Characterization and Corrosion Testing: These are mentioned as having been performed to show substantial equivalence to the predicate devices, indicating engineering performance rather than clinical outcome. The document states, "The ActiveLock Modular Hip System has been evaluated by use of the static and fatigue tests. It has been shown to be substantially equivalent to the predicate devices. [...] The components and materials of the ActiveLock™ Modular Hip System have been tested in corrosion. It has been shown that the materials of the system are resistant to corrosion." No specific acceptance criteria or study details (like sample size, methodology, or results) for these tests are provided.
Intended Use and Indications: These describe what the device is for, not how well it performs clinically.
FDA Clearance Letter: This letter confirms the FDA's finding of substantial equivalence but explicitly states a limitation regarding claims for HA-coated versions: "You may not label or in any way promote the HA coated versions of these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only)." This indicates that the 510(k) submission did not include data supporting enhanced clinical performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating the device meets those criteria because it is not present in the provided 510(k) summary. The document is typical of a 510(k) submission where the primary objective is to demonstrate substantial equivalence to existing devices based on design, materials, and intended use, rather than presenting a detailed clinical performance study with specific acceptance criteria.

Summary

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510(k) Summary prepared December 30, 1997

APR - 3 1998

Manufacturer Identification

Metagen, LLC 428 Technology Drive East Menomonie, Wisconsin 54751

Official Contact Person

Wesley D. Johnson President Telephone (715) 232-4880 Fax (715) 235-9570

DEVICE IDENTIFICATION

Proprietary Name

ActiveLock™ Modular Femoral Hip System

Common Name

Modular Hip Replacement System.

Classification Name and Reference

Hip joint metal/ceramic/polymer semi-constrained or nonporous uncemented prosthesis. 21 CFR 888.3353 [HA version]

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. 21 CFR 888.3358 [TPS version]

Proposed Regulatory Class

The Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel of FDA has recommended Class II, Performance Standards, for this device.

Device Product Codes

87 JDO - Device, Fixation, Proximal Femoral, Implant

SUBSTANTIAL EQUIVALENCE INFORMATION

The ActiveLock M Modular Femoral Hip System demonstrates substantial equivalence, relative to the intended use, materials and design, to several pre-amendment and post-amendment

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devices, including implants marketed by Biomet (Impact, K942027; Mallory-Head Modular Porous Series, K921181), Joint Medical Products Corporation/Johnson & Johnson (S-ROM, K851422, K912713, K913231), Wright Medical Technology (Infinity, K942115), and Smith & Nephew Richards (RMHS, K912593).

DEVICE DESCRIPTION

Intended Use

Design

The ActiveLock M Modular Femoral Hip System is a matrix of interchangeable components (STEM, BODY, ACTUATOR, FEMORAL HEAD) that can be locked together to form a single femoral hip prosthesis. A description of the components is given below.

Stem

The Stem component is cylindrical, straight, and fluted with a slot in the coronal plane that extends along the distal third of its length. The proximal aspect of the Stem is a smooth tubular cvlinder designed to mate with the Body component. The Stem component is manufactured from wrought Ti 6Al-4V alloy and is offered in a variety of lengths, straight or curved, to accommodate primary and revision surgery.

Body

The Body component is wedge-shaped and symmetrical in the coronal plane. Design variations of the Body include primary, revision, and calcar replacement components. All Body designs incorporate identical cylindrical bores for modular attachment to the Stem and the same modified Morse taper for attachment of Metagen Femoral Heads. All Body designs are available with either porous CpTi plasma spray or plasma-sprayed smooth HA (hydroxyapatite) coating. The Body component is manufactured from wrought Ti 6A1-4V alloy. When attached to the Stem component, the Body component provides fixation to the proximal metaphyseal region of the femur.

Actuator

The Actuator is manufactured of Nickel-Titanium alloy (NiT). It is a cylindrical, tubular locking component.

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Femoral Head

The Femoral Head is a CoCr alloy articulating component with a modified female Morse taper. The components are spherically ground and polished to 22 mm, 26 mm, and 32 mm diameters, and are available in four offsets -- 5 mm, 0 mm, +5 mm, and +10 mm.

Components are matched according to four distinct "FAMILY" designations. The four families are the "A" family, "B" family, "C" family, and the "D" family. The "A" family corresponds to the smallest sizes, the "B" and "C" family to the mid-range sizes, and the "D" family to the largest sizes. The Stem and Body components are only interchangeable within their respective families, and can only be locked by the Actuator in that family.

Composition/Materials

The ActiveLock "" Modular Femoral Hip System is composed of titanium alloy (Ti-6AI-4V ELI) conforming to ASTM Specification F136. The Femoral Head is made from wrought Co-Cr-Mo alloy conforming to ASTM Specification F1537.

The Actuator of the ActiveLock™ Modular Femoral Hip System is made from NiTi alloy, a nickel-titanium shape memory alloy. NiTi alloy is currently being used in a number of implant devices and has a long clinical history as an implant material. In addition, NiTi alloy is being used in orthopedic applications for bone anchors.

Mechanical Characterization

The ActiveLock " Modular Hip System has been evaluated by use of the static and fatigue tests. It has been shown to be substantially equivalent to the predicate devices.

Corrosion Testing

The components and materials of the ActiveLock™ Modular Hip System have been tested in corrosion. It has been shown that the materials of the system are resistant to corrosion.

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Canada Petersi a

Summary: Table of Substantial Equivalence

	SubjectDevice	Predicate Devices
MANUFACTURER	Metagen	Biomet	JointMedical/J&J	WrightMedicalTechnology	S&NRichards
SYSTEM NAME	Modular FemoralHip System	Impact(K942027)	Mallory-Head(K921181)	S-ROM(K851422,K912713,K913231)	Infinity(K942115)	ModularHipSystem(RMHS)(K912593)
DESIGN FEATURES
Cementless fixation	YES	YES	YES	YES	YES	YES
Modular proximalbody/stem	YES	YES	YES	YES	YES	YES
Straight cylindrical distalstem	YES			YES	YES	YES
Flexible distal stem	YES	YES	YES	YES	YES
Maximized projectedarea	YES	YES	YES	YES	YES	YES
Collarless	YES	YES	YES	YES		YES
Modular head withmodified Morse taper	YES	YES	YES	YES	YES	YES
MATERIALS
Ti-6Al-4V	YES	YES	YES	YES	YES	YES
NiTi alloy Actuator	YES
HA on proximal surfaces	YES			YES
TPS on proximalsurfaces	YES	YES	YES	YES	YES
Co-Cr-Mo Modular Head	YES	YES	YES	YES	YES	YES

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized lines or strokes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 1998

Mr. Wesley D. Johnson ·President Metagen, LLC 428 Technology Drive East Menomonie, Wisconsin 54751

K980020 Re : ActiveLock™ Modular Hip System Requlatory Class: II Product Codes: MEH, LPH, and JDI Dated: December 30, 1997 Received: January 5, 1998

Dear Mr. 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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:

You may not label or in any way promote the HA coated versions of these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only) --------------------------------------------------------------------------------------------------------------------------------------------------. . . . . . . . . . .................

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

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.

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Page 2 - Mr. Wesley D. Johnson

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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. 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 Regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 one regaration onerozon" (21 CFR 807.97) - Other general information on your responsibilities under the Act may be

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Page 3 - Mr. Wesley D. Johnson

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.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Device Name: ACTIVELOCK™ MODULAR FEMORAL HIP SYSTEM

The ActiveLock™ Modular Femoral Hip System is intended for primary or revision reconstruction, with or without bone cement, of the femoral portion of severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:

noninflammatory degenerative joint disease including osteoarthritis and avascular 1. necrosis;
1. rheumatoid arthritis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and,
1. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)Division of General Restorative Devices510(k) Number	K980020

Prescription Use X OR Over-The-Counter Use

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.