CARPAL ENGAGING WRIST FUSION PLATE

K974030 · Terray Corp. · HRS · Jan 21, 1998 · Orthopedic

Device Facts

• Record ID: K974030
• Device Name: CARPAL ENGAGING WRIST FUSION PLATE
• Applicant: Terray Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The various clinical indications for wrist arthrodesis are at the discretion of the surgeon but in general include: - rheumatoid wrist deformities requiring restoration of alignment and stability - carpal instabilities - severe unremitting wrist pain related to motion of the carpus - other damage to the wrist joint including post-traumatic arthrosis, infection and tumor resection.

Device Story

Carpal Engaging Wrist Fusion Plate is a surgical implant for wrist arthrodesis. Used by orthopedic surgeons in clinical/OR settings to stabilize wrist joint. Device provides structural support to restore alignment and stability in patients with rheumatoid deformities, carpal instabilities, or joint damage from trauma, infection, or tumors. Implant facilitates fusion by immobilizing carpal bones; helps alleviate chronic pain and restore function. Surgeon selects device based on clinical assessment of patient's wrist pathology.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing orthopedic fusion hardware.

Technological Characteristics

Metallic orthopedic fusion plate designed for carpal fixation. Device functions as a mechanical stabilizer for wrist arthrodesis. Specific material composition and ASTM standards not disclosed in provided text.

Indications for Use

Indicated for patients requiring wrist arthrodesis due to rheumatoid deformities, carpal instabilities, severe unremitting wrist pain, post-traumatic arthrosis, infection, or tumor resection.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1998

Ms. Teal Renals · Quality Assurance Manager Terray Corporation Jackson Lane Pine Grove Industrial Park Arnprior, Ontario K7S 3G8 CANADA

K974030 Re: Terray Carpal Engaging Wrist Fusion Plate Trade Name: Requlatory Class: II Product Code: HRS October 8, 1997 Dated: Received: October 23, 1997

Dear Ms. Renals:

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 controls provisions The general controls provisions of the Act 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 (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.

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Page 2 - Ms. Teal Renals

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.

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,

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

Enclosure

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## "510 (K) Notification"

510(k) Number (if known)

Device Name:

Carpal Engaging Wrist Fusion Plate

## INDICATIONS FOR USE:

The various clinical indications for wrist arthrodesis are at the discretion of the surgeon but in general include:

- rheumatoid wrist deformities requiring restoration of alignment and stability
- carpal instabilities
- severe unremitting wrist pain related to motion of the carpus
- other damage to the wrist joint including post-traumatic arthrosis, infection and tumor resection.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

peelle
(Division Sign-Off)

Division of General Restorative Devices 510(k) Number

**Prescription Use**

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

ない。

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