AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM

K061862 · Axiom Orthopaedics, Inc. · HSD · Aug 28, 2006 · Orthopedic

Device Facts

• Record ID: K061862
• Device Name: AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
• Applicant: Axiom Orthopaedics, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Aug 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The Axiom Shoulder Resurfacing System is indicated for use as a replacement of shoulder joints disabled by Rheumatoid arthritis with pain; Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis); Correction of functional deformity; Fractures of the humeral head; Traumatic arthritis. These components are single use only and are intended for cementless use.

Device Story

Humeral head prosthesis for hemi-shoulder replacement; designed for cementless implantation. Device features cobalt-chromium alloy (ASTM F-75) construction with plasma-sprayed titanium substrate and calcium phosphate coating (ASTM 1044/1147). Interior surface includes buttressed protrusions to restrict rotation. Geometry utilizes non-spherical, elliptical shape to mimic natural humeral head and maintain contact with Glenoid fossa throughout range of motion. Available in 14 sizes. Used by orthopedic surgeons in clinical settings to restore shoulder mobility, reduce pain, and correct alignment in patients with joint disability. Output is mechanical articulation of the shoulder joint.

Clinical Evidence

Bench testing only. Finite element analysis performed on smallest, middle, and largest sizes under 752 N load; maximum tensile Von-Mises Keel stress ranged from 170 to 219 MPa, yielding factors of safety between 2.1 and 2.6. Compliance with ASTM F1044-95 (shear testing), ASTM F1147-99 (tension testing), and ASTM F1160-05 (fatigue testing) for coatings.

Technological Characteristics

Cobalt-chromium-molybdenum alloy (ASTM F-75); plasma-sprayed titanium substrate; calcium phosphate coating (ASTM 1044, ASTM 1147). Elliptical articulating surface geometry. Cementless fixation via internal buttressed protrusions. 14 sizes (36-62mm diameter, 14-24mm thickness). Single-use.

Indications for Use

Indicated for patients requiring hemi-shoulder replacement with sufficient bone stock and intact/reconstructable rotator cuff. Conditions include rheumatoid arthritis, non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), functional deformity, humeral head fractures, and traumatic arthritis.

Regulatory Classification

Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

Predicate Devices

• Depuy Global CAP Resurfacing Replacement Shoulder (K033516)
• Biomet Copeland Resurfacing Humeral Heads (K010657)

Submission Summary (Full Text)

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K06186+ page 144

# 510(k) Summary for

AUG 2 8 2006

## Axiom Orthopaedics Shoulder Resurfacing System

- SPONSOR 1.
Axiom Orthopaedics, Inc. 285 West Side Avenue Suite 251 Jersey City, NJ 07305

| Contact Person: | Peter Verrillo |
|-----------------|----------------|
| Telephone: | 201-377-9129 |

Date Prepared: June 29, 2006

#### 2. DEVICE NAME

| Proprietary Name: | Axiom Orthopaedics Shoulder Resurfacing System |
|----------------------|-------------------------------------------------------------------------|
| Common/Usual Name: | Shoulder Resurfacing System |
| Classification Name: | Shoulder joint, humeral (hemi-shoulder), metallic uncemented prosthesis |

#### 3. PREDICATE DEVICES

| Depuy Global CAP Resurfacing Replacement Shoulder | K033516 |
|---------------------------------------------------|---------|
| Biomet Copeland Resurfacing Humeral Heads | K010657 |

#### 4. DEVICE DESCRIPTION

The Axiom Orthopaedics Shoulder Resurfacing System is a series of humeral heads that are designed to articulate with a resurfaced or non-resurfaced Glenoid fossa. The proposed humeral heads are manufactured from cobalt chromium alloy (ASTM F-75) and can be used as either a left or right configuration. The interior surface of the proposed Axiom components contains a pattern of buttressed protrusions that help restrict rotation of the device. In addition to the buttressed protrusion pattern, the interior surface is coated with a plasma spray titanium substrate and a calcium phosphate coating (ASTM 1044 and ASTM 1147, respectively).

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The proposed humeral heads have been designed to mimic the normal humeral head geometry by employing a non-spherical accurate shape. The shape of the humeral heads does not exceed the radius of curvature of the reamed Glenoid fossa. This helps to maintain contact between the humeral head and the Glenoid fossa throughout the range of motion. The humeral heads are available in 14 sizes.

#### INTENDED USE 5.

The Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation.

The Axiom Shoulder Resurfacing System is indicated for use as a replacement of shoulder joints disabled by

- . Rheumatoid arthritis with pa 1
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular . necrosis)
- Correction of functional defermity .
- Fractures of the humeral head .
- . Traumatic arthritis.

These components are single use only and are intended for cementless use.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed Axiom Orthopaedics Shoulder Resurfacing System, the Depuy Global CAP Resurfacing Replacement Shoulder and the Biomet Copeland Resurfacing Humeral Heads are all identical in that they all consist of humeral heads manufactured from cobalt-chromium-molybdenum alloy that are indicated for uncemented use only. Both the proposed product and the predicate devices are manufactured from cobalt chromium alloy that comply with ASTM F75. The interior surface of both the proposed and predicate device components contain a calcium phosphate coating for cementless use. Both the proposed and predicate devices are cementless humeral replacement systems that require minimal bone resection.

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Both the proposed product and the predicate devices have been designed to mimic the normal humeral head geometry. The Depuy predicate devices are available in diameters of 40, 44, 48, 52 and 56mm, all available with head heights of 15mm (short), 18mm (medium) or 2 1mm (large), and the proposed Axiom product will be available in diameters of 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, and 62 mm with varying thicknesses from 14mm - 24mm.

The only differences between the Axiom device and the predicate devices are that the predicate device includes grooves in the stemmed part of the prosthesis to resist rotation whereas the Axiom device in:ludes fixation features on the inner surface as well as the stemmed part of the head to resist rotation. Additionally, the Depuy predicate device uses a standard spherical method for their articulating surface whereas the proposed device incorporates an elliptical method. These differences do not affect safety or effectiveness of the device since the Axiom device is made of biocompatible materials and is designed similarly to the predicate devices to resist rotation.

#### 7. PERFORMANCE TESTING

A finite element analysis of humeral head loading under a simulated 752 N load was performed to determine the acceptability of the proposed product. The analysis was performed to ensure an acceptable factor of safety with respect to the component material properties, as specified by A.STM F-75. The sizes analyzed represented the smallest, the middle and the largest stzes of the system. The results of this analysis showed that the maximum tensile Von-Mises Keel stress for all of the sizes studied ranges from 170 to 219 MPa. For the given stresses, the factor of safety with respect to the material strength (450 Mpa) ranges from 2.6 to 2.1. The result of this load distribution will be much lower stresses resulting in a higher factor of safety for the Axiom Orthopaedics Shoulder Resurfacing System. The Axiom Orthopaedics Shoulder Resurfacing System components comply with the applicable requirements of the following standards

- F 1044-95, "Standard Test Method for Shear Testing of Porous Metal . Coatings"
- F 1147-99, "Standard Test Method for Tension Testing of Calcium Phosphate . and Metallic Coatings"

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- F 1 160 05 Standard Test Method for Shear and Bending Fatigue Testing of . Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
Additionally, this 510(k) premarket notification was written in consideration of the "Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis''.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 2 8 2006

Axiom Orthopaedics, Inc. % Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K061862

Trade/Device Name: Axiom Orthopaedics Shoulder Resurfacing System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: June 29, 2006 Received: July 6, 2006

Dear Ms. McNamara-Cullinane:

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 - Ms. Mary McNamara-Cullinane, RAC

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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Soubace Buelus
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Axiom Orthopaedics Shoulder Resurfacing System

Indications For Use:

The Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by reducing pain, restoring alignment, restoring flexion and extension movement, and resisting dislocation.

The Axiom Orthopaedics Shoulder Resurfacing System is indicated for use as a replacement of shoulder joints disabled by

- Rheumatoid arthritis with pain 1.
- 2. Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- 3. Correction of functional deformity
- 4. Fractures of the humeral head
- 5. Traumatic arthritis.

These components are single use only and are intended for cementless use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use__No (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buckner
Division Sign Off

Division of General, Restorative and Neurological Devices

510(k) Number K06/862