ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM

K062861 · Ascension Orthopedics, Inc. · HSD · Oct 31, 2006 · Orthopedic

Device Facts

• Record ID: K062861
• Device Name: ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
• Applicant: Ascension Orthopedics, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascension® HRA® System is intended for resurfacing of the humeral head due to: . Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis) . Mild or moderate humeral head deformity and / or limited motion . . Post-traumatic arthritis . Malunions of the humeral head . . Acute fractures of the humeral head . . Patients with an intact or reparable rotator cuff

Device Story

Ascension HRA is a semi-constrained, monolithic humeral head resurfacing prosthesis. Device replaces damaged humeral head bearing surface; restores anatomy with minimal bone resection. System includes eight anatomically designed head geometries with tapered, fluted stems for press-fit fixation. Used in orthopedic surgery; implanted by surgeons. Instrumentation provided for precise preparation. Highly polished bearing surface reduces friction; CP Titanium plasma spray coating on under-surface and stem promotes osseointegration. Benefits include restoration of joint function and motion in patients with arthritis or humeral head trauma.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, material composition, and design comparison to predicate devices.

Technological Characteristics

Materials: ASTM F-75 cast or ASTM F-1537 wrought Cobalt Chrome alloy; CP Titanium (ASTM F1580) plasma spray coating. Design: Semi-constrained, monolithic, press-fit humeral head prosthesis with tapered, four-fluted stem. Sizes: 8 geometries (40-56mm width, 15-21mm height). Sterilization: Provided sterile for single use.

Indications for Use

Indicated for patients with non-inflammatory or inflammatory arthritis (rheumatoid, osteoarthritis, avascular necrosis), mild/moderate humeral head deformity, limited motion, post-traumatic arthritis, malunions, or acute fractures of the humeral head, provided the rotator cuff is intact or reparable. Contraindicated in patients with infection, sepsis, osteomyelitis, osteoporosis, metabolic bone disorders, osteomalacia, rapid joint destruction/bone loss, or failed prior revision procedures.

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

• Biomet Copeland Humeral Resurfacing Head (K010664, and K051843)
• DePuy Global C.A.P. (K031971)

Submission Summary (Full Text)

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Page 38 of 95

# 510(k) SUMMARY

| SUBMITTER NAME: | Ascension Orthopedics, Inc.<br>8700 Cameron Road, C-100<br>Austin, TX 78754-3832 |
|-----------------|----------------------------------------------------------------------------------|
| | OCT 31 2000 |
| 510(k) CONTACT: | Glen Neally |
| | Phone: [phone] |
| TRADE NAME: | Ascension® HRA® |
| COMMON NAME: | Sterile Resurfacing Shoulder Joint Replacement Prosthesis |
| CLASSIFICATION: | 21 CFR 888.3690 |
| PRODUCT CODE: | HSD |
| PANEL: | Orthopedic |

#### PREDICATE DEVICES:

Biomet Copeland Humeral Resurfacing Head (K010664, and K051843) DePuy Global C.A.P. (K031971)

### DEVICE DESCRIPTION:

The Ascension® HRA® System includes an anatomically designed, semi-constrained, monolithic device designed for resurfacing of the humeral head (hemi-shoulder). The system is designed for non-cemented (i.e. press-fit) fixation. Each device is boxed individually and delivered sterile for single use. The system incorporates eight anatomically designed head geometries with appropriately sized stems. Head sizes are identified using width and height (in millimeters). The Ascension® HRA® device incorporates design features for replacing the damaged humeral head bearing surface and restoring normal anatomy with minimal bone resection. The stem is tapered and fluted to provide rotational as well as axial stability of the seated implant. System instrumentation, including a range of implant trials, is designed to offer precise implant preparation. The HRA device is made from Cobalt Chrome (ASTM F-1537 wrought or ASTM F-75 cast) and features a highly polished bearing surface with a CP Titanium plasma spray under-surface and stem coating to enhance osseointegration. No new materials are introduced with this device. Ascension HRA® System components will be manufactured by contract manufacturers per Ascension Orthopedics, Inc., specifications.

### INTENDED USE:

The Ascension® HRA® System is intended for resurfacing of the humeral head due to:

- . Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis)
- Mild or moderate humeral head deformity and / or limited motion .
- . Post-traumatic arthritis

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- Malunions of the humeral head .
- . Acute fractures of the humeral head
- . Patients with an intact or reparable rotator cuff

Contraindications:

- Infection, sepsis, and osteomyelitis .
- . Osteoporosis
- Metabolic disorders which may impair bone formation .
- . Osteomalacia
- . Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- . Revision procedures where other devices or treatments have failed

## BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of identical materials and nearly identical design features, demonstrates that the Ascension® HRA® device is substantially equivalent to the predicate device as indicated in the chart below:

| Specification /<br>Characteristic | Ascension<br>Orthopedics Inc<br>(AOI)<br>Humeral Resurfacing<br>Arthroplasty (HRA)<br>Device | Biomet / Copeland<br>Humeral<br>Resurfacing Head | DePuy / Global<br>C.A.P. |
|-----------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------|----------------------------------|
| FDA 510(k) clearance | K010664, and<br>K051843 | K010664, and<br>K051843 | K031971 |
| Use | Single use | Single use | Single use |
| Implantation duration | Longer than 30 days | Longer than 30 days | Longer than 30 days |
| Constraint | Semi-constrained | Semi-constrained | Semi-constrained |
| Articulating Surface | ASTM F-75 Co-Cr<br>Casting Alloy<br>or ASTM F1537<br>wrought Co-Cr | ASTM F-75 Co-Cr<br>Casting Alloy | ASTM F-75 Co-Cr<br>Casting Alloy |
| Under-Coating | CP Ti (ASTM F1580)<br>Plasma Spray Coating | CP Ti (ASTM F1580)<br>Plasma Spray Coating | Porocoat® Porous<br>Coating |
| Sizes | 8 | 8 | 10 |
| Width Range | 40mm - 56mm | 42.7mm - 54.0mm | 40mm - 56mm |

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| Height Range | 15mm – 21mm | 12.0mm – 27.0mm | 15mm – 21mm |
|--------------------------------------|-----------------|-----------------|-----------------|
| Radius Range | 20.2mm – 28.7mm | 25mm – 27.5mm | 20.1mm – 30.8mm |
| Shell Thickness (head) | Same | Same | Same |
| Under-surface Flat | Yes | No | Yes |
| Primary Fixation | Press Fit Stem | Press Fit Stem | Press Fit Stem |
| Tapered Stem | Yes | Yes | Yes |
| Stem Cross-Section | Four-Fluted | Four-Fluted | Four-Fluted |
| Variable Stem Lengths | Yes | Yes | Yes |
| Cannulated | Yes | Yes | Yes |
| Instrumentation | | | |
| Minimal Bone Removal | Yes | Yes | Yes |
| Penetration of Intramedullary Canal | No | No | No |
| Easy Conversion to Stemmed Component | Yes | Yes | Yes |

Similarities of the Ascension® HRA® device and the Biomet Copeland and the DePuy Global C.A.P. devices include: All devices have the same indications for use; All devices are made of the same industry standard materials: No new materials are introduced; Minimal bone removal surgical procedure for all device; Anatomic head sizes; All devices incorporate a press-fit stem as the primary fixation method; All devices are intended for surgical implantation longer than 30 days: All devices are intended for single use only.

Summary:

The Ascension® HRA® System is identical functionally, and had the same indications for use when compared to the predicate devices, and is fabricated from the same materials as the predicate devices. Dimensionally, the Ascension® HRA® device is nearly identical to the predicate devices. Devices for the subject and predicate systems are provided sterile in individual packages. Therefore, the Ascension " HRA device is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 3 1 2006

Ascension Orthopedics, Inc. % Mr. Glen Neally Vice President of RA/QA/CA 8700 Cameron Road, C-100 Austin, Texas 78754-3832

Re: K062861

Trade/Device Name: Ascension® Human Resurfacing Arthroplasty Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: September 15, 2006 Received: September 25, 2006

Dear Mr. Neally:

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 - Mr. Glen Neally

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.

For Palo R
Mark N. Melkerson Dspvm

Division of General, Restorati and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use

510(K) Number: K. 062.861

Ascension® Humeral Resurfacing Arthroplasty Device Name:

### Indications for Use:

The Ascension® HRA® device is intended for resurfacing of the humeral head due to:

- . Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis).
- . Mild or moderate humeral head deformity and / or limited motion.
- . Post-traumatic arthritis.
- . Malunions of the humeral head.
- . Acute fractures of the humeral head
- . Patients with an intact or reparable rotator cuff.

#### Contraindications:

- . Infection, sepsis, and osteomyelitis
- . Osteoporosis
- . Metabolic disorders which may impair bone formation
- . Osteomalacia
- . Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- . Revision procedures where other devices or treatments have failed.

| Prescription Use | X | OR | Over-The-Counter Use |
|----------------------------|---|----|----------------------------|
| (Part 21 CFR 801Subpart B) | | | (Part 21 CFR 801Subpart C) |

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

| (Division Sign-Off) | |
|-----------------------------------|--------------------------------------------------------|
| Division of General, Restorative, | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| and Neurological Devices | |
| 510(k) Number | K06861 |