APEX MODULAR ACETABULAR CUP

K031110 · Apex Surgical, LLC · LPH · May 22, 2003 · Orthopedic

Device Facts

• Record ID: K031110
• Device Name: APEX MODULAR ACETABULAR CUP
• Applicant: Apex Surgical, LLC
• Product Code: LPH · Orthopedic
• Decision Date: May 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex Modular™ Acetabular Cup is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobait chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and 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

The Apex Modular™ Acetabular Cup is an uncemented, porous-coated hip prosthesis component. It consists of a titanium alloy shell with a sintered commercially pure titanium bead coating for bone ingrowth, paired with a ram-extruded UHMWPE liner. The device is implanted by a surgeon during total hip replacement procedures. It articulates with cobalt-chromium or ceramic femoral heads (28 or 32 mm). The liner is secured via a 19° taper and locking ring mechanism. The device provides a stable acetabular surface to restore joint function and mobility in patients with degenerative or traumatic hip conditions. It is intended for single-use implantation.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes liner retention studies performed per FDA guidance documents.

Technological Characteristics

Materials: Titanium alloy shell, commercially pure (CP) titanium sintered bead porous coating, ram-extruded UHMWPE liner. Design: 19° taper with PE locking ring, full profile shell with 14° rim flare. Sterilization: Ethylene oxide (liners). Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients requiring total hip replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, congenital dislocation, revision of failed prior treatments, or femoral neck/trochanteric fractures.

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

• DePuy Pinnacle™ Acetabular Cup (K000306 and K001534)
• Wright Medical Lineage™ Acetabular cup (K002149)

Submission Summary (Full Text)

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MAY 222003

510(K) Summary

K031110

# Apex Modular™ Acetabular Cup

## May 12, 2003

| 1. Submitter: | Apex Surgical, LLC<br>12 Harding Street<br>Suite 202<br>Lakeville, MA 02347 |
|---------------|-----------------------------------------------------------------------------|
|---------------|-----------------------------------------------------------------------------|

Contact: Edward J. Cheal, Ph.D. Managing Director [phone] (voice) [phone] (fax)

#### 2. Device Name

| Proprietary Name: | Apex Modular™ Acetabular Cup |
|----------------------|----------------------------------------------------------------------------------------|
| Common Name: | Acetabular cup, uncemented |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-<br>coated uncemented prosthesis |
| Regulatory Class: | Class II per 21 CFR §888.3358 |

#### 3. Intended Use

The Apex Modular™ Acetabular Cup is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobait chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and 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™ Acetabular Cups are manufactured of titanium alloy, with a sintered bead porous coating (commercially pure titanium, irregular bead geometry). The liners are manufactured of ram extruded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or ceramic, 28 or 32 mm diameter, with various offsets.

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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 upper right of the word "Surgical".

### 5. Predicate Device Comparison

Substantial equivalence is claimed to the DePuy Pinnacle™ Acetabular Cup and the Wright Medical Lineage™ Acetabular cup. The table below compares the features and characteristics of the Apex Modular Acetabular Cup to these predicate devices.

| | Apex Modular<br>Acetabular Cup | DePuy<br>PinnacleTM<br>Acetabular Cup<br>(K000306 and<br>K001534) | Wright Medical<br>Lineage<br>Acetabular Cup<br>(K002149) |
|-----------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------|
| INTENDED USE | | | |
| Primary and revision<br>total hip replacement | Yes, cementless | Yes, cementless | Yes, cementless |
| DESIGN | | | |
| Liner engagement | 19° taper with<br>PE locking ring | "VIP Taper" with<br>PE locking ring | 19° taper with PE<br>locking ring |
| Minimum PE<br>thickness | 6 mm | 6 mm | >4 mm |
| Liner options | Neutral, and 15°<br>hooded | Neutral, 4 mm<br>lateralized, 10°<br>angled, and 15°<br>hooded | Neutral, 4 mm<br>lateralized, and<br>15° hooded |
| Shell options | No hole and<br>three hole (plus<br>apical hole) | No hole, three<br>hole, spiked, and<br>multihole (8-12<br>holes), plus<br>apical hole (all) | No hole and three<br>hole (plus apical<br>hole) |
| Head diameters | 28 and 32 mm | 28, 32, and 36<br>mm | 22.25, 28 and 32<br>mm |
| Shell profile | Full profile, 14°<br>rim flare | Full profile,<br>hemispherical | Full profile, 14°<br>rim flare |
| MATERIALS | | | |
| Liner | UHMWPE (ram<br>extruded, ETO<br>sterilized) | UHMWPE (ram<br>extruded,<br>radiation cross-<br>linked, gas<br>plasma<br>sterilized) | UHMWPE (ram<br>extruded, ETO<br>sterilized) |
| Shell | Titanium alloy | Ti alloy | Ti alloy |
| Porous coating | CP titanium<br>sintered beads | CP titanium<br>sintered beads | CP titanium<br>sintered beads |

These cups use similar materials, porous coatings, design options, and liner locking mechanisms. Liner retention studies were performed on the Apex Modular liners as per the relevant FDA guidance documents.

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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 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, with three stylized lines representing the wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2003

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

Re: K031110

Trade/Device Name: Apex Modular™ Acetabular Cup Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint/metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: April 4, 2003 Received: April 8, 2003

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

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

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

sincerely yours,

Mark N. Milliken

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™ Acetabular Cup

The Apex Modular™ Acetabular Cup is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and 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)

Mark A. Milham

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

510(k) Number K031110

Prescription Use X (Per 21 CFR §801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)