STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5

K111068 · Skeletal Dynamics, LLC · KYI · Dec 30, 2011 · Orthopedic

Device Facts

• Record ID: K111068
• Device Name: STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
• Applicant: Skeletal Dynamics, LLC
• Product Code: KYI · Orthopedic
• Decision Date: Dec 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Skeletal Dynamics Stablyx CMC Arthroplasty Implant set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This implant is intended for uncemented, press fit use.

Device Story

Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for first metacarpal carpometacarpal (CMC) joint replacement. Device features a highly polished, saddle-shaped (toroidal) articular surface mirroring normal anatomy of the first metacarpal base. It articulates against the trapezium to restore flexion-extension, abduction-adduction, and opposition. Implanted via uncemented, press-fit technique into the medullary canal. Used by orthopedic surgeons in clinical settings to address joint pain, instability, or limited mobility resulting from arthritis or trauma. Benefits include restoration of joint function and pain relief.

Clinical Evidence

No clinical data. Evidence based on engineering analysis and cadaveric testing.

Technological Characteristics

Hemi monoblock prosthesis; Cobalt Chrome (CoCr) construction; Titanium Plasma Spray (TPS) coated stem for biological fixation; saddle-shaped (toroidal) articular surface; five available sizes; sterile; uncemented press-fit design.

Indications for Use

Indicated for patients with rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation/bone loss of the first metacarpal, presenting with painful, unstable thumbs or limited range of motion.

Regulatory Classification

Identification

A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

Predicate Devices

• Ascension, PyroCarbon Saddle CMC (K061451)
• BioPro Modular Thumb Implant (K052596)

Submission Summary (Full Text)

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DEC 3 0 2011

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# 510(k) Summary of Safety and Effectiveness Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set

April 14, 2011

## Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 102 Miami, FL 33176 Tel: [phone] Fax: [phone] Contact: Ana M. Escagedo, Vice President Email: [e-mail]

Establishment Registration Number: 3006742481

## Trade Name, Common Name. Classification:

Trade Name Stablyx CMC Arthroplasty Implant Set Common Name Prosthesis, wrist, carpal trapezium 21 CFR §888.3770 Classification Product Code KYI Class II Class

## Predicate Devices:

Ascension, PyroCarbon Saddle CMC (K061451) BioPro Modular Thumb Implant (K052596)

## Description of the Device:

The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) joint. The single piece prosthesis has a highly polished, saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates against the saddle surface of the trapezium, allowing for flexionextension, abduction-adduction and opposition motions.

The prosthesis is available in five sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile.

The Stablyx CMC Arthroplasty System is comprised of:

- Multiple sized hemi ioint prosthesis .
- System specific instrumentation .

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#### Intended Use:

The Skeletal Dynamics Stablyx CMC Arthroplasty Implant set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This implant is intended for uncemented, press fit use.

#### Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Stablyx CMC Arthrodesis Implant Set to the predicate devices is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness.

#### Performance Testing:

Engineering analysis and cadaveric testing demonstrated that the Stablyx CMC Arthrodesis Implant Set is substantially equivalent to devices currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

#### Conclusion:

The Skeletal Dynamics Stablyx CMC Arthrodesis Implant Set is substantially equivalent to the predicate devices identified in this premarket notification.

KIIIDPA

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

DEC 3 0 2011

Skeletal Dynamics, Inc. % Ms. Ana Escagedo 8905 SW 87th Avenue Suite 201 Miami, Florida 33176

Re: K111068

Trade/Device Name: Stablyx CMC Arthroplasty System Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: December 10, 2011 Received: December 12, 2011

Dear Ms. Escagedo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Ana Escagedo

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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: Stablyx CMC Arthroplasty Implant Set

Indications For Use:

The Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion. This implant is intended for uncemented, press fit use.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Thuner

Sign-Oft) (Divis . >f Surgical, Orthopedic, Divisi . and Nesprative Devices

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K11068 510(k) Number.