TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+

K123982 · Encore Medical L.P. · KWS · Jan 23, 2013 · Orthopedic

Device Facts

• Record ID: K123982
• Device Name: TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
• Applicant: Encore Medical L.P.
• Product Code: KWS · Orthopedic
• Decision Date: Jan 23, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Joint replacement is indicated for patients suffering from disability due to: - noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid; - . rheumatoid arthritis; - . correction of functional deformity: - . humeral fracture. This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications

Device Story

Turon e+ Glenoid is a shoulder joint prosthesis component; keeled and pegged design. Manufactured using standard UHMWPE and highly cross-linked UHMWPE infused with Vitamin E. Intended for cemented shoulder arthroplasty. Used by orthopedic surgeons in clinical settings to replace damaged glenoid surfaces. Device restores joint function and reduces disability in patients with degenerative disease, arthritis, or fractures. Provides mechanical articulation surface for humeral head component.

Clinical Evidence

Bench testing only. Testing included cyclic displacement, glenoid pull-out, impact resistance, small punch testing, tensile testing, oxidation testing, biocompatibility, and cytotoxicity. No clinical data provided.

Technological Characteristics

Shoulder joint metal/polymer semiconstrained cemented prosthesis. Materials: Standard UHMWPE and highly cross-linked UHMWPE infused with Vitamin E. Form factor: Keeled and pegged glenoid component. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients with disability due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis of humeral head/glenoid), rheumatoid arthritis, functional deformity, or humeral fracture; also indicated for salvage of failed surgical attempts. For cemented applications.

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

• DJO Surgical Encore Shoulder System (K080402)
• DJO Surgical Highly Crossed-Linked VE Polyethylene Material UHMWPE Tibial Insert (K091956)

Submission Summary (Full Text)

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# 510(k) Summary

Date: December 19, 2012

Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Michaela Norris Regulatory Affairs Associate Phone: [phone] Fax: [phone] Email: [e-mail]

| Product | Classification | Product Code |
|------------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Turon e+ Glenoid | Class II | KWS - Shoulder joint metal/polymer<br>semiconstrained cemented prosthesis per 21<br>CFR 888.3660<br>PAO - Shoulder joint metal/polymer<br>semiconstrained cemented prosthesis per 21<br>CFR 888.3660 |

Description: The purpose of this application is to include a new keeled and pegged glenoid for the Turon Shoulder System manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.

### Indications for Use:

Joint replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid;
- . rheumatoid arthritis;
- . correction of functional deformity:
- . humeral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts.

This system is to be used for cemented applications

#### Predicate Devices:

DJO Surgical Encore Shoulder System - K080402 DJO Surgical Highly Crossed-Linked VE Polyethylene Material UHMWPE Tibial Insert - K091956

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications sterilization, packaging and intended use.

Non-Clinical Testing: Testing included: cyclic displacement test, glenoid pull-out test, impact resistance, small punch testing, tensile testing, oxidation testing, biocompatibility, and cytotoxicity.

Clinical Testing: None provided.

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

Letter dated: January 23, 2013

Encore Medical, L.P. % Ms. Michaela Norris Regulatory Affairs Associate 9800 Metric Boulevard Austin, Texas 78758

Re: K123982

Trade/Device Name: Turon e+ Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semiconstrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, PAO Dated: December 19, 2012

Received: December 26, 2012

Dear Ms. Norris:

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 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. Michaela Norris

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). regulations 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.htmfor 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K123982 510(k) Number (if known): J

Device Name: Turon e+ Glenoid

Indications for Use:

## Turon e+ Glenoid Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid;
- . rheumatoid arthritis;
- correction of functional deformity; .
- humeral fracture. .

This device may also be indicated in the salvage of previously failed surgical attempts.

This system is to be used for cemented applications

Prescription Use X (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)

Krishna Asundi, PhD Division of Orthopedic Devices