ANATOMICAL SHOULDER FRACTURE SYSTEM

K062029 · Zimmer GmbH · KWS · Oct 31, 2006 · Orthopedic

Device Facts

• Record ID: K062029
• Device Name: ANATOMICAL SHOULDER FRACTURE SYSTEM
• Applicant: Zimmer GmbH
• Product Code: KWS · Orthopedic
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Anatomical Shoulder™ Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following: Complex 3 and 4 part fractures of the proximal humerus with subluxation of the head fragment; Complex 3 and 4 part fractures of the proximal humerus with loosening of the spongiosa in the head fragment; Complex 3 and 4 part fractures of the proximal humerus with additional cross split of the head fragment; Fracture instability after osteosynthesis of 3 and 4 fragments of the proximal humerus; Posttraumatic necrosis of the humeral head; Posttraumatic arthrosis after humeral head fracture. The Anatomical Shoulder Fracture stem is intended for cemented or cementless use.

Device Story

Prosthetic system for proximal humerus and glenoid replacement; treats complex fractures and post-traumatic conditions. Components include stem, baseplate, screw, and head. Features spikes on proximal stem and baseplate for tuberosity anchoring; includes suture holes for fixation. Stem compatible with Anatomical Shoulder System glenoid components and Inverse/Reverse humeral cup for conversion surgery in cases of irreparable rotator cuff. Used in orthopedic surgery; implanted by surgeons. Provides stable fixation of humeral tuberosities; restores joint function; enables conversion to reverse arthroplasty if needed.

Clinical Evidence

Bench testing only. Performance testing confirmed all components meet or exceed predetermined performance criteria for intended use.

Technological Characteristics

Modular shoulder prosthesis consisting of stem, baseplate, screw, and head. Features include proximal spikes for tuberosity anchoring and integrated suture holes. Designed for cemented or cementless fixation. Materials and manufacturing methods consistent with predicate shoulder arthroplasty systems.

Indications for Use

Indicated for patients requiring total, hemi, or fracture shoulder arthroplasty due to complex 3 or 4-part proximal humerus fractures (with subluxation, spongiosa loosening, or cross-split), fracture instability post-osteosynthesis, post-traumatic humeral head necrosis, or post-traumatic arthrosis.

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

• Aequalis Shoulder Fracture System & Aequalis Shoulder (K060209)
• Global Fx Humeral Stem and Global Advantage Humeral Head (K984541)
• Zimmer Trabecular Metal Reverse Shoulder System (K052906)
• Anatomical Shoulder (K030259)

Reference Devices

• Anatomical Shoulder System (K030259)
• Anatomical Shoulder Inverse/Reverse humeral cup (K053274)

Submission Summary (Full Text)

{0}------------------------------------------------

K062029

OCT 3 1 2006

1/2

# Summary of Safety and Effectiveness

| Submitter: | Zimmer GmbH<br>P.O. Box<br>CH-8404 Winterthur, Switzerland |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mason W. Robbins<br>Regulatory Affairs Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | July 17, 2006 |
| Trade Name: | Anatomical Shoulder™ Fracture System |
| Common Name: | Hemi- and Total Shoulder Arthroplasty Prosthesis |
| Classification Name<br>and Reference: | prosthesis, shoulder, semi-constrained,<br>metal/polymer cemented; 21 CFR § 888.3660;<br>prosthesis, shoulder, hemi-, humeral, metallic<br>uncemented, 21 CFR § 888.3690 |
| Predicate Devices: | Aequalis Shoulder Fracture System & Aequalis<br>Shoulder, manufactured by Tornier S.A., K060209,<br>cleared March 2, 2006<br>Global Fx Humera! Stem and Global Advantage<br>Humeral Head, manufactured by Depuy<br>Orthopedics, Inc., K984541, cleared January 14,<br>1999.<br>Zimmer Trabecular Metal™ Reverse Shoulder<br>System, manufactured by Zimmer, Inc., K052906,<br>cleared December 19, 2005.<br>Anatomical Shoulder, manufactured Zimmer GmbH<br>(Formerly Centerpulse Orthopedics), K030259,<br>cleared April 24, 2003. |
| Device Description: | The Anatomical Shoulder Fracture System is<br>designed specifically to treat complex 3 or 4 part<br>proximal humerus fractures requiring hemi- or total<br>shoulder arthroplasty. The Anatomical Shoulder<br>Fracture System may be used with or without bone<br>cement. The Anatomical Shoulder Fracture System |

:

{1}------------------------------------------------

Kd2029 2/

consists of four components, a stem, baseplate. screw and head. The Anatomical Shoulder Fracture System baseplate offers right and left side-specific versions in order to appropriately match the original shoulder anatomy with respect to right and left humeral anatomy.

The Anatomical Shoulder Fracture System head is also designed to articulate with the glenoid components of the Anatomical Shoulder System (K030259). The Anatomical Shoulder Fracture System stem is also designed to accept the Anatomical Shoulder Inverse/Reverse humeral cup (K053274) for conversion from hemi- or total shoulder arthroplasty to an inverse/reverse shoulder arthroplasty in situations when the rotator cuff is irreparable and the patient is experiencing severe instability of the shoulder joint.

The Anatomical Shoulder Fracture System stem is comparable in shape and size to stems traditionally used for hemi- and total shoulder arthroplasty. The Anatomical Shoulder Fracture System stem, however, has two features which distinguish it as a stem designed for treatment of proximal humeral fractures. The proximal surface of the humeral stem and much of the surface of the baseplate offer spikes which assist in the stable anchoring of the humeral tuberosities to the stem and allow for primary stability of the tuberosities. The Anatomical Shoulder Fracture System stem and baseplate also offer several suture holes to allow initial stable fixation of the humeral tuberosities with sutures.

The Anatomical Shoulder Fracture System is substantially equivalent to the predicate devices in regards to its intended use, design, size ranges, materials and manufacturing methods.

Non-Clinical Performance and Conclusions: Performance testing indicates that all components meet or exceed predetermined performance criteria for their intended use.

Comparison to Predicate Devices:

Performance Data (Nonclinical and/or Clinical):

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three human figures are nestled within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc % Mr. Mason W. Robbins, MS, RPCV, CCRP Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K062029

Trade/Device Name: Anatomical Shoulder™ Fracture System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: October 13, 2006 Received: October 16, 2006

Dear Mr. Robbins:

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.

{3}------------------------------------------------

Page 2 - Mr. Mason W. Robbins, MS, RPCV, CCRP

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/dsma/dsmamain/html

Sincerely vours.

Mark N. Molkerson, M.S.

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# K662029

//

## Indications for Use

### 510(k) Number (if known):

Device Name:

Anatomical Shoulder™ Fracture System

### Indications for Use:

The Anatomical Shoulder™ Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:

- Complex 3 and 4 part fractures of the proximal humerus with subluxation of the head . fragment;
- Complex 3 and 4 part fractures of the proximal humerus with loosening of the spongiosa . in the head fragment;
- Complex 3 and 4 part fractures of the proximal humerus with additional cross split of the . head fragment;
- Fracture instability after osteosynthesis of 3 and 4 fragments of the proximal humerus; .
- . Posttraumatic necrosis of the humeral head;
- . Posttraumatic arthrosis after humeral head fracture.

The Anatomical Shoulder Fracture stem is intended for cemented or cementless use.

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)

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

**510(k) Number** K061064