SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT

K103104 · Howmedica Osteonics Corp. · KWS · Nov 22, 2010 · Orthopedic

Device Facts

• Record ID: K103104
• Device Name: SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
• Applicant: Howmedica Osteonics Corp.
• Product Code: KWS · Orthopedic
• Decision Date: Nov 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Special Orthopaedic Solutions Glenoid Shoulder Component is a single use device intended for cemented fixation within the prepared glenoid fossa of the shoulder.

Device Story

Glenoid component for total shoulder arthroplasty; implanted in glenoid fossa via cement fixation. Device features UHMWPE bearing surface with 10-degree posterior buildup to restore joint alignment; includes cobalt-chromium alloy X-ray marking wire. Offered in multiple sizes with modified peg geometry. Used by orthopedic surgeons in clinical/surgical settings. Output is a prosthetic joint surface; facilitates joint articulation; restores shoulder function; reduces pain in patients with degenerative or traumatic joint disease.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence supported by dynamic evaluation of glenoid loosening per ASTM F2028-08 and engineering analysis of polyethylene thickness.

Technological Characteristics

Materials: ASTM F-648 UHMWPE (glenoid body), ASTM F-90 cobalt-chromium alloy (X-ray marker). Design: Semi-constrained, cemented prosthesis. Features 10-degree posterior buildup and modified peg geometry. Dimensions: Sizes 5, 7, and 9.

Indications for Use

Indicated for patients with aseptic necrosis of the humeral head; painful, disabling shoulder joint disease (degenerative, rheumatoid, or post-traumatic arthritis); proximal humeral fracture/dislocation; or revision of previous unsuccessful shoulder procedures. Indicated for clinical management where arthrodesis or alternative reconstruction is less likely to achieve satisfactory results. Intended for cemented use only.

Regulatory Classification

Identification

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Osteonics All Polyethylene Glenoid Shoulder Component (K950521)

Submission Summary (Full Text)

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K103104

11:

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# 510(k) Summary of Safety and Effectiveness: SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT

NOV 2 2 2010

| Proprietary Name: | Special Orthopaedic Solutions Glenoid |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shoulder Component Common Name: | Total Joint Shoulder Component |
| Classification Name and Reference: | Shoulder Joint Metal/Polymer Semi-<br>Constrained Cemented Prosthesis 21 CFR<br>§888.3660 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87 KWS |
| For Information contact: | Avital Merl-Margulies<br>Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |
| Date Prepared: | 11/22/2010 |

#### Description:

The Special Orthopaedic Solutions Glenoid Shoulder Component is designed for use as the glenoid component in a total shoulder arthroplasty. The glenoid is manufactured from ASTM F-648 ultra high molecular weight polyethylene (UHMWPE) and features an xray marking wire on its medial surface manufactured from ASTM F-90 cobalt chromium alloy. The glenoid component will be offered in three sizes 5, 7, & 9 with a 10 degree posterior buildup. Additional size 9 glenoid components both with and without posterior buildup will also be offered with new peg geometry.

#### Intended Use:

The Special Orthopaedic Solutions Glenoid Shoulder Component is a single use device intended for cemented fixation within the prepared glenoid fossa of the shoulder.

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#### Indications for Use:

The indications for use of the total shoulder arthroplasty include:

- . Aseptic necrosis of the humeral head.
- . Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- . Proximal humeral fracture and/or dislocation.
- . Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.

The glenoid components are intended for cemented use only.

#### Proposed Modification:

The subject Special Orthopaedic Solutions Glenoid Shoulder Component has the same indications for and intended use, material, operational principles, and bearing sizes as the previously cleared Osteonics All Polyethylene Glenoid Shoulder Component cleared under K950521. The subject Special Orthopaedic Solutions Glenoid Shoulder Component device consists of a rotation to the bearing surface of the implant to increase the posterior thickness to help restore joint alignment. Additional size 9 glenoid components both with and without posterior buildup will also be offered with a modified peg geometry.

### Summary of Data:

Testing has been performed to demonstrate equivalence of the subject device to its predicate device. The testing includes dynamic evaluation of glenoid loosening via ASTM F2028-08 and an engineering analysis on the polyethylene thickness.

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

Howmedica Osteonics Corporation % Ms. Avital Merl-Margulies Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

NOV 2 2 2010

Re: K103104

Trade/Device Name: Specia! Orthopaedic Solutions Glenoid Shoulder Component Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: October 14, 2010 Received: October 20, 2010

Dear Ms. Merl-Margulies:

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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 – Ms. Avital Merl-Margulies

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" (21 CFR 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 vours.

Sincerely yours,

For Ato

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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K103104

*Special 510(k)*

Special Orthopaedic Solutions Glenoid Skoulder Component

Indications for Use

NOV 2 2 2010

510(k) Number (if known): K103104

Device Name: Special Orthopaedic Solutions Glenoid Shoulder Component

Indications for Use:

The indications for use of the total shoulder arthroplasty include:

- Aseptic necrosis of the humeral head. .
- Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis or post-traumatic arthritis.
- Proximal humeral fracture and/or dislocation. .
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other 。 procedure.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.

The glenoid components are intended for cemented use only.

| Prescription Use | X |
|-----------------------------|--------|
| (Part 21 CFR 801 Subpart D) | |
| | AND/OR |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) | |

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OF NEEDED)

Concurrence of DRBFC Office of Detice Evaluation (ODE)

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(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103104

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