NEER III TOTAL SHOULDER SYSTEM

K994350 · Smith & Nephew, Inc. · KWS · May 23, 2000 · Orthopedic

Device Facts

• Record ID: K994350
• Device Name: NEER III TOTAL SHOULDER SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: May 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neer III Total Shoulder System is indicated for use as an orthopedic implant for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. The Neer III Total Shoulder System is intended for the following: Proximal Humeral Prosthesis - (1) complex, acute fracture-dislocations of the humeral head (e.g., trauma - three and four-part injuries in the Neer classification, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities. Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) – severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. This device is intended only for cemented fixation.

Device Story

Neer III Total Shoulder System; orthopedic implant for humeral head replacement or total shoulder arthroplasty. Humeral stems manufactured from cast CoCr alloy; available in multiple diameters and head heights for intra-operative tensioning. Features suture-wire holes in lateral fins for tuberosity re-attachment. Intended for cemented fixation into prepared humeral canal. Used in conjunction with compatible glenoid components or as hemi-arthroplasty against unresurfaced glenoid. Implanted by orthopedic surgeons in clinical/surgical settings. Provides structural replacement of damaged glenohumeral articular surfaces; restores joint function; alleviates intractable chronic pain. Benefits include improved mobility and pain relief for patients with severe degenerative or traumatic shoulder conditions.

Clinical Evidence

Bench testing only. Performance evaluated via range of motion analysis, finite element analysis, fatigue testing, stem strength testing, and package integrity testing. Results were consistent with Neer II and other predicate devices.

Technological Characteristics

Humeral stems: cast CoCr alloy. Glenoid components: UHMWPE. Fixation: cemented. Design: modular with variable stem diameters (8, 10, 12mm) and head heights (15, 19, 22, 26mm). Features lateral fins with suture-wire holes. Non-active, mechanical orthopedic implant.

Indications for Use

Indicated for patients requiring partial or total shoulder joint replacement due to complex acute/chronic fractures, fracture-dislocations, avascular necrosis, or severe joint destruction from rheumatoid, traumatic, or osteoarthritis, cuff tear arthroplasty, septic arthritis, or radiation necrosis. Contraindicated for patients lacking adequate scapular bone support for glenoid components.

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

• Neer II Total Shoulder System 3M
• Modular Total Shoulder System - 3M
• Aequalis Shoulder System - Tornier S.A.

Reference Devices

• Neer II Shoulder glenoid components
• Coffeld Modular Shoulder glenoid components
• Anatomic glenoid components

Submission Summary (Full Text)

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# MAY 2 3 2000

### SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitter's Name | Smith & Nephew, Inc., Orthopaedic Division |
|---------------------------|---------------------------------------------------------------------------------------------------|
| Submitter's Address | 1450 East Brooks Road, Memphis, Tennessee 38116 |
| Submitter's Telephone No. | 901-399-5363 |
| Contact Person | Neal Defibaugh, Manager Clinical/Regulatory Affairs |
| Date of Summary | April 20, 2000 |
| Proprietary Name | Neer III Total Shoulder System |
| Device Common Name | Shoulder Joint Prosthesis |
| Device Classification | Shoulder Joint metal/polymer semi-constrained cemented prosthesis, 21 CFR 888.3660 -<br>Close III |

#### Substantial Equivalent Information

The Neer III Total Shoulder System is similar to the following shoulder systems:

- 1. Neer II Total Shoulder System 3M
- 2. Modular Total Shoulder System - 3M
- 3. Aequalis Shoulder System - Tornier S.A.

All of the devices listed above are indicated for the same use as total shoulder systems, and are similar in design to the Neer III Total Shoulder System. The safety and effectiveness of the Neer III Total Shoulder System is based on the long history of use of these devices in the market place.

#### Device Description

Neer III humeral stems are manufactured from cast CoCr (cobalt chrome) alloy and are available in three stem diameters (8, 10 & 12mm). Four head heights, 15, 19, 22 & 26mm, are available, to allow accurate tensioning of the joint intra-operatively. The 25mm radius of curvature of the heads is constant throughout the stem to be used as a total shoulder replacement in conjunction with various glenoid components. Suture-wire holes are located in two laterally orientated fins to optimize re-attachment of the tuberosities.

The implants in the system are intended fixation into a prepared humeral canal. Neer III humeral stems can be used in conjunction with a compatible glenoid component, such as Neer II Shoulder glenoid components, Coffeld Modular Shoulder glenoid components, Anatomic glenoid components, or in a hem-arthroplasty against an unresurfaced glenoid process.

#### Indications for Use

The Neer III Total Shoulder System is indicated for use as an orthopedic implant for the replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively,

### The Neer III Total Shoulder System is intended for the following:

Proximal Humeral Prosthesis - (1) complex, acute fracture-dislocations of the humeral head (e.g., trauma - three and four-part injuries in the Neer classification, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapport a glenoid component or must engage in moderately heavy activities.

Total Shoulder Arthroplasty (when used in compatible glenoid component) - severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.

This device is intended only for cemented fixation.

#### Technological Characteristics:

The Neer III Total Shoulder System is substantially equivalent to the above predicate devices. The Neer is a modification of the Neer II device and has the same technological characteristics as the Neer predicate devices. Range of Motion, finite element analysis, fatigue testing, stem strength, and package integrity testing were performed on the Neer III prosthesis. Test results were consistent with the Neer II and predicate devices. The Anatomic Glenoid is substantially equivalent to the Neer II UHMWPE glenoid component predicate device. It is manufactured of the same material with the only difference being a more anatomical "pear-shaped" design.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 3 2000

Mr. Neal Defibaugh Manager Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

Re: K994350

Trade Name: Neer III Total Shoulder System Regulatory Class: III Product Code: KWS and HSD Dated: April 27, 2000 Received: April 28, 2000

Dear Mr. Defibaugh:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your became is substantially equivalent (for the indications for use above and we nave determined the marketed in interstate commerce prior to May 28, 1976, the stated in the energoure) to device Amendments, or to devices that have been reclassified in enactificin date of the Frodical Dortes Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provisions of at to the general control provisions of the Act. The general therefore, market the do received requirements for annual registration, listing of devices, control provisions of the five, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remance ripproval), it they of our can Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Pood and Diagon may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket I ntification. The FDA finding of substantial equivalence of your device to a legally marketed nverlicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Mr. Neal Defibaugh

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Donna R. Lochner.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Premarket Notification Indications Enclosure

Page 1 of 1

1994350 510(k) Number (if known): _

Device Name: Neer III Total Shoulder System

Indications for Use:

The Neer III Total Shoulder System is indicated for use as an orthopedic implant for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively.

The Neer III Total Shoulder System is intended for the following:

Proximal Humeral Prosthesis - (1) complex, acute fracture-dislocations of the humeral head (e.g., trauma - three and four-part injuries in the Neer classification, or head impression (eactures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.

Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) – severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.

This device is intended only for cemented fixation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Lochner

Distision Sion-Off (Division of Ceneral Restorative Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use (Optional Format 1-2-96)