ECLIPSE TOTAL ANKLE IMPLANT

K061749 · Kinetikos Medical, Inc. · HSN · Nov 22, 2006 · Orthopedic

Device Facts

• Record ID: K061749
• Device Name: ECLIPSE TOTAL ANKLE IMPLANT
• Applicant: Kinetikos Medical, Inc.
• Product Code: HSN · Orthopedic
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients effected with severe rheumatoid, post-traumatic, or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement. The Eclipse Total Ankle replacement system is contraindicated for patients with: -active sepsis or infection -insufficient bone or osteonecrosis -insufficient blood supply such that healing activity may be compromised -Charcot's neuropathy or other peripheral neuropathy -age, weight or activity levels that introduce unnecessary risk of failure -insufficient bone or musculature such that proper component positioning or alignment is not possible.

Device Story

Eclipse Total Ankle Implant; semi-constrained metal/polymer ankle prosthesis. System replaces tibio-talar joint; components sized to accommodate human ankle anatomy. Materials: Cobalt Chrome (ASTM F75) with Titanium Plasma Spray (ASTM 1580) for tibia/talar components; U.H.M.W.Pe. (ASTM 648-00) for bearing; Titanium Alloy (ASTM F-136) for bone screws. Used in surgical arthroplasty; requires bone cement. Device restores joint function; benefits patients with severe arthritis or failed prior surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and material specifications.

Technological Characteristics

Semi-constrained metal/polymer cemented ankle prosthesis. Materials: Cobalt Chrome (ASTM F75) with Titanium Plasma Spray (ASTM 1580), U.H.M.W.Pe. (ASTM 648-00), and Titanium Alloy (ASTM F-136). System includes various size components for anatomical fit.

Indications for Use

Indicated for patients with severe rheumatoid, post-traumatic, or degenerative arthritis requiring prosthetic replacement of the tibio-talar joint, or revision of prior ankle surgery. Contraindicated in patients with active sepsis/infection, insufficient bone/osteonecrosis, compromised blood supply, Charcot's or peripheral neuropathy, high-risk age/weight/activity levels, or insufficient bone/musculature for proper positioning.

Regulatory Classification

Identification

An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Depuy Agility Total Ankle Orthopedic Implant (K020541)

Submission Summary (Full Text)

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#### APPENDIX I SUMMARY OF SAFETY AND EFFECTIVENESS

For

#### Eclipse Total Ankle Implant

| 1. Submitter: | Contact Person: | NOV 22 2005 |
|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Kinetikos Medical, Inc.<br>6005 Hidden Valley Rd. Suite 180<br>Carlsbad, CA 92011 | John G. Spampinato<br>V.P., Quality Assurance<br>Kinetikos Medical, Inc.<br>6005 Hidden Valley Road Suite 180<br>Carlsbad, CA 92011 | |

[phone]

FAX [phone]

Date Prepared: June 15, 2006

- 2. Proprietary Name: Eclipse Total Ankle Implant Common Name: Ankle Prosthesis Classification Name Ankle joint metal/polymer semi-constrained Regulatory Class: Cemented prosthesis; Class II, per 21 CFR 888.3110 Device Product Code: 87 HSN
## 3. Predicate or legally marketed devices which are substantially equivalent:

-Depuy Agility Total Ankle Orthopedic Implant (K020541) cleared May 20, 2002

### 4. Description of Device

The Eclipse Total Ankle implant is intended for use in total ankle joint replacement arthroplasty. The system consists of various size range components to accommodate variations in human ankle anatomy.

Materials: -Cobalt Chrome, per ASTM F75, with Titanium Plasma Spray Coating per ASTM 1580 (Tibia Plates / Talar components) -U.H.M.W.Pe., per ASTM 648-00 (Bearing) -Titanium Alloy per ASTM F-136 (Bone screws)

Function: The Eclipse Total Ankle system functions as a replacement for the ankle joint.

#### 5. Intended Use

The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients effected with severe rheumatoid, post-traumatic, or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement. The Eclipse Total Ankle replacement system is contraindicated for patients with:

-active sepsis or infection

-insufficient bone or osteonecrosis

-insufficient blood supply such that healing activity may be compromised -Charcot's neuropathy or other peripheral neuropathy

-age, weight or activity levels that introduce unnecessary risk of failure

-insufficient bone or musculature such that proper component positioning or alignment is not possible.

#### Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:

There are no significant differences between the Eclipse Total Ankle Implant and other total ankle joint replacement systems currently being marketed which would adverselv affect the use of the product. The Eclipse Total Ankle Implant employs the same materials and basic mechanical features as the predicate, legally marketed device specified in section 3 (DePuy Agility total ankle arthroplasty system).

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kinetikos Medical, Inc. % Mr. John G. Spampinato Vice President, Quality Assurance 6005 Hidden Valley Road, Suite 180 Carlsbad, California 92011

NOV 2 2 2006

Re: K061749

Trade/Device Name: Eclipse Total Ankle Implant Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN Dated: October 30, 2006 Received: October 31, 2006

Dear Mr. Spampinato:

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 - Mr. John G. Spampinato

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]. 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 vours.

Barbara Buettner

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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# Indications for Use

510(k) Number (if known):

Device Name: Eclipse Total Ankle

Indications For Use:

The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients affected with severe rheumatoid, post-traumatic, or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Congurrence of CDRH, Office of Device Evaluation (ODE)

Oabare thulmp for msm,

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

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510(k) **Number** K061749

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