AEQUALIS SHOULDER FRACTURE SYSTEM

K994392 · Tornier · KWS · Mar 10, 2000 · Orthopedic

Device Facts

• Record ID: K994392
• Device Name: AEQUALIS SHOULDER FRACTURE SYSTEM
• Applicant: Tornier
• Product Code: KWS · Orthopedic
• Decision Date: Mar 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. Including humeral head fracture and displaced 3 or 4 part proximal humeral fractures.

Device Story

Aequalis Shoulder Fracture System is a 3-part modular shoulder prosthesis for total shoulder replacement or hemi-arthroplasty. System components include interchangeable humeral heads, a humeral stem, and an optional glenoid component. The humeral stem features a metaphyseal design to facilitate bone graft filling and bony bridge formation between tuberosities, with anterior-posterior fins for tuberosity positioning. Humeral heads attach via Morse taper, allowing rotational adjustment for anatomical fit. The device is implanted by surgeons in a clinical setting to restore joint function and reduce pain. The modular design allows for conversion from primary hemi-arthroplasty to total shoulder replacement. The system accommodates various patient anatomies through multiple head and stem sizes. The device is supplied sterile via gamma radiation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modular shoulder prosthesis consisting of humeral stem, humeral heads, and glenoid component. Materials include metal alloys (Titanium or cobalt-chromium-molybdenum) and ultra-high molecular weight polyethylene. Fixation via bone cement. Sterilization via gamma radiation (min 2.5 Mrad, SAL 10^-6) per EN552. Instruments sterilized via steam at 274°F for 18 minutes.

Indications for Use

Indicated for patients with traumatic or pathologic shoulder conditions resulting in glenohumeral joint fractures, specifically humeral head fractures and displaced 3 or 4 part proximal humeral fractures. For use by surgeons experienced in total or hemi-arthroplasty.

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.”

Submission Summary (Full Text)

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MAR 1 C 200

K994392

510(k) Premarket Notification Aequalis Shoulder Fracture System September 2. 1999

Fig. 1 of 5

#### 510(k) SUMMARY of Safety and Effectiveness Information

In accordance with the Food and Drug Administration Rule to implement provisions of the safe Medical devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Aequalis Shoulder Fracture System.

| Manufacturer: | TORNIER, S.A. |
|----------------------|--------------------------------------------------------------------------------------|
| | Rue du Doyen Gosse |
| | 38330 SAINT-ISMIER / France |
| | Registration No : 9610667 |
| US Representative: | Mr. David W. SCHLERF |
| | BUCKMAN Company, Inc. |
| | 200 Gregory Lane, Suite C-100 |
| | Pleasant Hill, CA 94523-3389 |
| Date: | September 2, 1999 |
| Contact Person: | Anne LE ROUZO |
| | Regulatory Affairs Manager |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis - 21CFR888.3660 |

# 1. Classification:

\$888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) 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 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 Titanium or 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). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §888.3.

The Orthopedic and Rehabilitation Devices Panel assigned the unique device classification Product Code 87KWS to this device.

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#### 2. Voluntary standard:

pg 275

Various voluntary performance standards are utilized. They include Tornier, S.A. Standard Operating Procedures (SOP), vendor certifications and qualification procedures. Quality System Regulations (OSR). ISO9001 & EN46001 specifications, and European CE Marking,

# 3. Labeling / Packaging:

Labeling complies with all FDA requirements in effect at the time of device review and clearance. Warning and caution statements are displayed as appropriate. Professional information is available from Tornier and is supplied with all product ordered. Please obtain and review all product information before using the system. Only the information supplied with the product is to be considered current and complete.

The Aequalis Shoulder Fracture System offers all components in double blister-type peel packs. This is an industry typical package obtained from commercial suppliers of such packaging.

# 4. Device Description:

Overview. The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Though the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemi-arthrosplasty to a total shoulder replacement.

Device Description. The Aequalis Shoulder Fracture System is a typical 3 part system consisting of interchangeable humeral heads, a humeral stem and, if used as a total shoulder, a glenoid component.

The Aequalis Shoulder Open stem for Fracture is available in 3 diameters (6.5, 9 and 12), with the same length. The geometry of the meaphyseal part has been designed to allow the filling by bone graft and to improve the knitting of the bones. The goal of the metaphyseal shape is to make a "bony bridge" between the tuberosities. In order to allow extraction of the prosthesis in case of revision, two slits have been designed to break the bony bridge. Anterior-posterior fins extending from diaphyseal portion form a convex bearing area allowing adequate positioning and synthesis of the greater tuberosity. The stem is used cemented in the diaphyseal part.

Various heads may be assembled to the stem in different configurations thus accommodating large variations in patient size and anatomy. The head is fixed on the stem on a Morse taper. It is impacted onto the stem on an impacting support. Subsequent revisions may be accomplished if necessary by reoparetion and separation of the head and the stem. The taper fit heads may be rotated about the axis of the Morse taper. The reverse surface of the heads has series of holes drilled around the female Morse taper every 45°. Because the female Morse taper of the head is eccentric, rotation of the head before fully seating the male and female tapers produces eight possible offset combinations for the orientation of the humeral head radius. The rotational adjustability of the humeral articulating surface expands the surgical flexibility of the system. The articulating surface of each head is designed to mate with either the natural glenoid (hemi-

shoulder applications) or the available glenoid implants (total shoulder applications).

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The Aequalis glenoid components are pear-like in shape, to avoid friction with the deep surface of the rotator cuff.

Open Stem for fracture: 3 dia. (6.5. 9 and 12 mm) with 1 length

| Humeral Heads: | 37mm x 13.5mm | 50mm x 16mm |
|----------------|---------------|-------------|
| | 39mm x 14mm | 50mm x 19mm |
| | 41mm x 15mm | 52mm x 19mm |
| | 43mm x 16mm | 52mm x 23mm |
| | 46mm x 17 | 54mm x 23mm |
| | 48mm x 18mm | 54mm x 27mm |

3 sizes (small, medium, large) Glenoid:

Each component of the system is individually part coded for ease identification. The offered combinations of stem, head and glenoid sizes accommodate a wide range of anatomical variations and circumstances.

Only surgeons fully experienced in total and hemi-Contraindications and Cautions. arthroplasty surgical technique of the shoulder should utilize the device. Please contact Tornier about available instructional course demonstrations and bio-skills workshops.

# 5. Packaging and Sterilization Information:

The prostheses are supplied sterile from Tornier. The technique used to achieve the sterilization is known as gamma radiation sterilization dose of at least 2.5 Mrad is utilized. The sterility assurance level (SAL) is 10°. The validation of the sterilization has been carried out according to the standard EN552.

The implant is contained in a double sealed blister pack in order to maintain sterility. Once the packaging is opened, the implant must never be resterilized. In case of packaging is damaged, the implant must be rejected.

The instruments required to properly use the device are provided non-sterile. They must be decontaminated, cleaned and sterilized prior to each surgery. All packaging, labeling and shipping materials must be removed from the instruments prior any operation. The recommended sterilization method is steam sterilization at 274°F for 18 minutes.

# 6. Summary of Safety and Effectiveness Information.

This summary contains information upon which a determination of substantial equivalence could be based. Selected device testing demonstrates the functional equivalence of the Aequalis Shoulder Fracture System. A feature comparison table is used to graphically present important parameters of the available systems. The comparison table is identified as Table 1, located after the Class III Summary section.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAR 1 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David W. Schlerf Representing Tornier, S.A. Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389

Re: K994392 Trade Name: Æqualis® Shoulder Fracture System Regulatory Class: III Product Code: KWS Dated: November 21, 1999 Received: December 28, 1999

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 comply with the GMP regulation 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 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.

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Page 2 – Mr. David W. Schlerf

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 [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Kamil Mayer

Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 994392

#### Equalis® Shoulder Fracture System Device Name:

#### Indications For Use:

Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. Including humeral head fracture and displaced 3 or 4 part proximal humeral fractures.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Vuan Lazaro

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ion Sign-Off) of General Restorative I

Prescription Use X OR
(Per 21 CFR 801.109)

Over-The-Counter Use __ (Optional format 1-2-96)