SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS

K041533 · Synthes (Usa) · HWC · Sep 1, 2004 · Orthopedic

Device Facts

• Record ID: K041533
• Device Name: SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
• Applicant: Synthes (Usa)
• Product Code: HWC · Orthopedic
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Peri-prosthetic Locking Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with Synthes locking plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of non-unions or malunions.

Device Story

Synthes Peri-Prosthetic Screws are metallic bone fixation fasteners designed for orthopedic surgery. Features include self-tapping blunt tip, stardrive mechanism, and flat head profile with rounded edges. Available in lengths 8mm to 12mm. Screws are used by surgeons in clinical settings to secure long bone fractures (humerus, femur, tibia), particularly in periprosthetic or osteopenic bone scenarios, by engaging with threaded holes of existing Synthes LCP plating systems. The device provides mechanical stability to bone segments, facilitating healing of fractures, non-unions, or malunions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener. Features self-tapping blunt tip, stardrive mechanism, and flat head profile. Dimensions: 8mm to 12mm lengths. Designed for compatibility with Synthes LCP plating systems. Mechanical fixation principle.

Indications for Use

Indicated for fixation of long bones (humerus, femur, tibia) in conjunction with compatible Synthes locking plates. Applicable for periprosthetic fractures, osteopenic bone, non-unions, and malunions.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes 4.0/5.0 mm Locking Screws

Submission Summary (Full Text)

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SEP = 1 2004

Ko4/533

## 510(k) Summary 3.0

Page _________ of ___

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Peri-Prosthetic Screws |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener. |
| Predicate Devices: | Synthes 4.0/5.0 mm Locking Screws |
| Device Description: | The new Synthes 4.0/5.0mm Peri-prosthetic Locking Screws<br>feature a self-tapping blunt tip, stardrive mechanism, and have a<br>flat head profile with rounded edges. They are available in lengths<br>ranging from 8mm to 12mm. The threads on the head of each<br>locking screw are designed to engage with the threaded holes of<br>currently marketed Synthes LCP® plating systems. |
| Intended Use: | The Synthes Peri-prosthetic Locking Screws are intended for<br>fixation of various long bones, such as the humerus, femur and<br>tibia, in conjunction with Synthes locking plates that accept 4.0/5.0<br>mm locking screws. They are also for use in fixation of<br>periprosthetic fractures, osteopenic bone, and fixation of non-<br>unions or malunions. |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 1 2004

Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pensylvania 19301

Re: K041533

Device Name: Synthes (USA) Peri-Prosthetic Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 7, 2004 Received: June 8, 2004

Dear Ms. Boyle:

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.

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## Page 2 - Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse organ and inding 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 If you desire specific at noliance 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 other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Milken

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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Indications for Use

510(k) Number (if known):

K04/1533

Device Name:

2.0

Synthes (USA) Peri-Prosthetic Screws

Indications for Use:

The Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the The Synthes Perfel Tostical Serows are meith Synthes locking plates that accept 4.0/5.0 mm
humerus, femur and tibia, in conjunction with Synthes locking plates actespense beg humerus, temur and tibla, in confulience with officition fractures, osteopenic bone, and fixation of non-unions or malunions.

Prescription Use
(Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number: K041533