SYNTHES CALCANEAL PLATE

K020401 · Synthes (Usa) · HRS · May 8, 2002 · Orthopedic

Device Facts

• Record ID: K020401
• Device Name: SYNTHES CALCANEAL PLATE
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: May 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Calcaneal Plate is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

Device Story

The Synthes Calcaneal Plate is a flat, metallic bone fixation device designed for the lateral side of the calcaneus. It features multiple arms to accommodate various screws for fracture stabilization. The device is available in right and left versions. It is intended for use by surgeons in an operating room setting to stabilize complex extra-articular and intra-articular fractures or to secure osteotomies. By providing rigid fixation, the plate supports bone healing and structural alignment, potentially improving patient recovery outcomes following calcaneal trauma or corrective surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use characteristics.

Technological Characteristics

Material: Stainless steel. Form factor: Flat metal plate with multiple arms for screw fixation. Configuration: Right and left versions for lateral calcaneal application. Class II bone fixation plate (21 CFR 888.3030).

Indications for Use

Indicated for patients requiring fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

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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MAY 0 8 2002

K020401

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### 3. Summary of Safety and Effectiveness Information

| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull<br>[phone] ext. 7191 |
| Name of the Device | Synthes Calcaneal Plate |
| Device Classification(s) | Class II, §888.3030 - Plate, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes<br>Calcaneal Plate to be substantially equivalent to another legally<br>marketed device. |
| Device Description | The Synthes Calcaneal Plate is a flat metal plate with multiple arms<br>that can accommodate a variety of screws. It designed to be applied to<br>the lateral side of the calcaneus and comes in right and left versions. |
| Indications | The Synthes Calcaneal Plate is intended for fixation of complex extra-<br>articular and intra-articular fractures and osteotomies of the calcaneus. |
| Material | Stainless Steel |

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CONFIDENTIAL

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 0 8 2002

Mr. Matthew M. Hull, RAC Senior Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, PA 19301

Re: K020401

Trade/Device Name: Synthes Calcaneal Plate Regulation Number: 888.3030 Regulation Name: Solo.5050
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 5, 2002

Received: February 7, 2002

Dear Mr. Hull:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated) 75 the enactment date of the Medical Device Amendments, or to conniner of the for to rite) 20, 2017 - 11:57
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been roomstiled in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, mainer 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 If your device 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 or cary I 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

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## Page 2 -- Mr. Matthew M. Hull, RAC

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Miriam C. Provost
for Celia Witte, Ph.D., M.D.

Celia 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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#### 2. Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

OdOYO/

Synthes Calcaneal Plate

The Synthes Calcaneal Plate is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020401

Synthes(USA) Synthes Calcaneal Plate 510(k) CONFIDENTIAL