The Apex Modular™ Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis:
. Rheumatoid arthritis:
Correction of functional deformity; .
Congenital dislocation: .
Revision procedures where other treatments or devices have failed; .
. Femoral neck and trochanteric fractures of the proximal femur.

Device Description

The Apex Modular Hip Stem consists of three modular components, with various sizes available for each component: the porous coated femoral stem, a modular neck that connects to the proximal end of the femoral stem, and a modular head that connects to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. The modular heads are available in standard diameters so as to fit appropriate commercially available acetabular components of the surgeons' choosing. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular Hip Stem may be used in conjunction with the Link® SPII® Acetabular Cup for total hip arthroplasty.
The femoral stem and neck components are manufactured from titanium alloy, and the head components are manufactured from wrought cobalt chromium alloy, the same materials used to manufacture the predicate hip stems and heads, respectively. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray. The alignment pin in the femoral stem is manufactured from wrought cobalt chromium alloy.

AI/ML Overview

The provided document is a 510(k) summary for the Apex Modular™ Hip Stem, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The document highlights the following:

Intended Use: The Apex Modular Hip Stem is intended for use as the femoral component of a primary total hip replacement for conditions like non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, congenital dislocation, revision procedures, and femoral neck and trochanteric fractures.
Device Description: It consists of three modular components: a porous coated femoral stem, a modular neck, and a modular head. Materials are titanium alloy for stem and neck, and cobalt chromium alloy for the head. The proximal metaphyseal region of the femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray.
Predicate Device Comparison: Substantial equivalence is claimed to the S-ROM® Femoral Stem and the Biomet Modular Hip System. The document includes a table comparing design features and materials.
Performance Testing Mentioned: "Performance testing of the modular stem has been completed as per the relevant FDA guidance documents, including assembly testing of the neck-stem modular connection and fatigue testing of the assembled device. Performance testing of the plasma sprayed unalloyed (CP) titanium coating was completed as per the relevant FDA guidance documents with data in the referenced Device Master File."

Missing Information:

The document does not provide:

A table of acceptance criteria and reported device performance.
Details of a specific study designed to prove the device meets acceptance criteria.
Sample sizes for test or training sets.
Data provenance.
Number or qualifications of experts.
Adjudication methods.
Information on MRMC comparative effectiveness studies.
Standalone performance data.
Type of ground truth used or how it was established.

This type of 510(k) submission primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, and that any differences do not raise new questions of safety and effectiveness, often supported by standard mechanical/material testing outlined in FDA guidance documents rather than clinical studies with human subjects.

Summary

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510(K) Summary K000788

Apex Modular™ Hip Stem

May 5, 2000

Submitter: Apex Surgical™, LLC 39 Taunton Green Suite 202 Taunton, MA 02780

Contact: Edward J. Cheal, Ph.D. Managing Director (508) 884-9611 (voice) (508) 884-9816 (fax)

2. Device Name

Proprietary Name: Apex Modular™ Hip Stem Common Name: Hip prosthesis, uncemented Classification Name: Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis Regulatory Class: Class II per 21 CFR §888.3358

3. Intended Use

The Apex Modular Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis:
. Rheumatoid arthritis:
Correction of functional deformity; .
Congenital dislocation: .
Revision procedures where other treatments or devices have failed; .
. Femoral neck and trochanteric fractures of the proximal femur.

4. Device Description

The femoral stem and neck components are manufactured from titanium alloy, and the head components are manufactured from wrought cobalt chromium alloy, the same materials used to manufacture the predicate hip stems and heads, respectively. The proximal metaphyseal region of each size femoral stem is circumferentially coated with

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Image /page/1/Picture/0 description: The image shows the logo for Apex Surgical. The logo consists of a stylized letter A on the left, followed by the words "Apex Surgical" in a bold, sans-serif font. The letters are all black, and there is a small trademark symbol to the right of the word "Surgical".

unalloyed titanium applied by plasma spray. The alignment pin in the femoral stem is manufactured from wrought cobalt chromium alloy.

5. Predicate Device Comparison

Substantial equivalence is claimed to the S-ROM® Femoral Stem and the Biomet Modular Hip System. The table below compares the features and characteristics of the Apex Modular Hip Stem to these predicate devices.

	Apex ModularHip Stem	S-ROM®Femoral Stem(K913231, K934412,and K954935)	Biomet ModularHip System(K921274)
INTENDED USE
Primary and revision hipreplacement, non-cemented use	Yes	Yes	Yes
DESIGN
Plasma spray coating	Yes	No (sinteredbeads)	Yes
Proximal coating (only)	Yes	Yes	Yes
Modular head	Yes	Yes	Yes
Modular stem	Yes - modularneck	Yes - modularsleeve	Yes - modulardistal stem
Straight distal stem	Yes	Yes	Yes
Fluted stem	Yes	Yes	Yes
Distal slot(s)	Yes - 1 or 2slots	Yes - 1 slot	Yes - 1 slot
Proximal steps	Yes	Yes	No
MATERIALS
Titanium alloy (Ti6Al4V)stem and neck	Yes	Yes	Yes
Cobalt chromium alloyhead	Yes	Yes	Yes
Titanium porous coating	Yes - unalloyed	Yes - unalloyed	Yes - Ti6Al4V

The two most significant differences between the Apex Modular hip stem and the two predicate hip stems relate to the design of the stem modularity (modular neck versus modular stem and sleeve for the S-ROM® or modular distal stem for the Biomet Modular) and the porous coating (plasma sprayed CP titanium versus sintered bead CP titanium for the S-ROM® or plasma sprayed titanium alloy for the Biomet Modular). Performance testing of the modular stem has been completed as per the relevant FDA guidance documents, including assembly testing of the neck-stem modular connection and fatigue testing of the assembled device. Performance testing of the plasma sprayed unalloyed (CP) titanium coating was completed as per the relevant FDA guidance documents with data in the referenced Device Master File.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2000 AUG

Edward J. Cheal, Ph.D. Managing Director Apex Surgical, LLC 39 Taunton Green Suite 202 Taunton, Massachusetts 02780

Re: K000788

Trade Name: Apex Modular™ Hip Stem Regulatory Class: II Product Code: LPH Dated: May 11, 2000 Received: May 12, 2000

Dear Dr. Cheal:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your bected. B r (x) xe is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreater) to teal Device Amendments, or to devices that have been reclassified in chactifient unto of the Federal Food, Drug, and Cosmetic Act (Act): You may, therefore, market the device, subject to the general control provisions of the Act. The general thereolo, incribed of the Act include requirements for annual registration, listing of devices, condor provisions of the or the , labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. arretmig Jour as a revealent 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. Failure to mopolitish the GMP regulation may result in regulatory action. 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. 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.

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Page 2 - Edward J. Cheal, Ph.D.

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 premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Donna R. Lochner.

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 Device Name: Apex Modular™ Hip Stem K 000788

The Apex Modular™ Hip Stem is intended for use as the femoral component of a The Apcx Moudlar - Tip Stom to infernoral hip stem is intended for uncemented fixation primary total hip replacement. This forthering in a prosthesis may be used for the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
Rheumatoid arthritis; ●
Correction of functional deformity; �
Congenital dislocation; .
Revision procedures where other treatments or devices have failed; .
Femoral neck and trochanteric fractures of the proximal femur.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Vochner

510(k) Number

Prescription Use_ X (Per 21 CFR §801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)

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.