APEX MODULAR HA HIP STEM

K043123 · Apex Surgical, LLC · LPH · Feb 10, 2005 · Orthopedic

Device Facts

• Record ID: K043123
• Device Name: APEX MODULAR HA HIP STEM
• Applicant: Apex Surgical, LLC
• Product Code: LPH · Orthopedic
• Decision Date: Feb 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex Modular™ HA Hip Stem is intended for use as the femoral component of a primary or revision 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 Story

Modular femoral hip prosthesis for uncemented total hip arthroplasty; consists of titanium alloy femoral stem, modular neck, and modular head (cobalt chromium or alumina ceramic). Proximal metaphyseal region features plasma-sprayed unalloyed titanium coating with optional hydroxyapatite (HA) layer. Modular design allows surgeon to select stem, neck, and head combinations to optimize anatomical fit, length, and lateral offset. Used in clinical settings by orthopedic surgeons during primary or revision hip replacement procedures. Provides structural support and fixation to the femur; intended to restore joint function and alleviate pain associated with degenerative disease, fractures, or deformity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V) stem/neck; cobalt chromium or alumina ceramic heads; unalloyed titanium plasma spray coating; optional hydroxyapatite (HA) coating. Design: Modular femoral stem with proximal stabilization (horizontal steps), distal round cross-section, distal slots, and ridges. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for primary or revision total hip replacement in patients requiring uncemented femoral fixation. Conditions include non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, congenital dislocation, failed prior treatments, and proximal femoral fractures (neck/trochanteric).

Regulatory Classification

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.

Predicate Devices

• HA Mallory/Head® Porous Femoral Stem (K021403)
• Apex Modular™ Hip System (K000788)

Reference Devices

• Apex K2 hip stem (K041950)
• Apex Modular Acetabular Cup (K031110)

Submission Summary (Full Text)

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FEB 1 0 2005

**510(K) Summary**

K 043123 p. 1/2

# Apex Modular™ HA Hip Stem

November 3, 2004

1. Submitter: Apex Surgical, LLC 12 Harding Street Suite 202 Lakeville, MA 02347 Contact: Edward J. Cheal, Ph.D. Managing Director [phone] (voice) [phone] (fax)

## 2. Device Name

Proprietary Name: Apex Modular™ HA 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™ HA Hip Stem is intended for use as the femoral component of a primary or revision 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 Apex Modular™ HA 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. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular HA Hip Stem may be used in conjunction with the Apex Modular Acetabular Cup (K031110) for total hip arthroplasty.

The femoral stems (and modular necks) are manufactured from titanium alloy. The Apex Modular HA stems can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray, with an optional hydroxyapatite (HA)

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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 serif font. The letters are all black, and the word "Surgical" is slightly smaller than the word "Apex". There is a trademark symbol to the right of the word "Surgical".

coating on top of the titanium coating. As in the predicate Apex Modular stem, the alignment pin in the stem is manufactured from wrought cobalt chromium alloy.

## 5. Predicate Device Comparison

Substantial equivalence is claimed to the HA Mallory/Head® Porous Femoral Stem distributed by Biomet (K021403) and the Apex Modular™ Hip System (K000788). The table below compares the features and characteristics of the Apex Modular™ HA Hip Stem to these predicate devices:

| | Apex Modular™<br>HA Hip Stem | Apex Modular™<br>(K000788) | HA Mallory/<br>Head® Porous<br>Femoral Stem<br>(K021403) |
|---------------------------------------------------------------|------------------------------|----------------------------|----------------------------------------------------------|
| INTENDED USE | | | |
| Primary and revision hip<br>replacement, non-<br>cemented use | Yes | Yes | Yes |
| DESIGN | | | |
| Porous coated | Yes - HA on<br>plasma spray | Yes - plasma<br>spray | Yes - HA on<br>plasma spray |
| Proximal coating (only) | Yes | Yes | Yes |
| Modular head | Yes | Yes | Yes |
| Modular neck | Yes | Yes | No |
| Tapered stem | No | No | Yes |
| Distal Cross-sectional<br>shape | Round | Round | Round |
| Distal slot(s) | Yes | Yes | No |
| Distal flutes | Yes - ridges | Yes - ridges | No |
| Proximal stabilization | Horizontal steps | Horizontal steps | Fins |
| MATERIALS | | | |
| Titanium alloy (Ti6Al4V)<br>stem and neck | Yes | Yes | Yes |
| Cobalt chromium or<br>alumina ceramic heads | Yes (both) | Yes (both) | Yes (both) |
| Titanium porous coating | Yes - unalloyed | Yes - unalloyed | Yes - unalloyed |
| Hydroxyapatite coating | Yes | No | Yes |

The stem design is the same as the predicate Apex Modular stem, updated to share modular heads and necks with the Apex K2 hip stem (K041950). The plasma spray titanium coating is identical to the plasma spray coating on the Apex Modular and K2 stems, with the addition of the option of a plasma sprayed hydroxyapatite (HA) coating on top of the plasma sprayed titanium; this coating is similar to the predicate HA Mallory/Head femoral stem. The most significant difference between these devices is that the Apex Modular HA stem employs modular necks (and heads) similar to the Apex Modular™ hip system, whereas the HA Mallory/Head stems have modular heads (only).

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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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2005

Edward J. Cheal, Ph.D. Managing Director Apex Surgical, LLC 12 Harding Street Suite 202 Lakeville, Massachusetts 02347

Re: K043123

Trade/Device Name: Apex Modular™ HA Hip Stem Regulation Number: 21 CFR 888.3358 and 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, MEH

Dated: November 3, 2004 Received: November 12, 2004

Dear Dr. Cheal:

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 (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 - Edward J. Cheal, Ph.D.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Mellares

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): K043123

Device Name: Apex Modular™ HA Hip Stem

Indications For Use:

The Apex Modular™ HA Hip Stem is intended for use as the femoral component of a primary or revision 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. .

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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and in currological

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**510(k) Number** K043123