OSTEO COMPRESSION CONDYLE SCREW SYSTEM

K971321 · Osteonics Corp. · HRS · Jul 9, 1997 · Orthopedic

Device Facts

• Record ID: K971321
• Device Name: OSTEO COMPRESSION CONDYLE SCREW SYSTEM
• Applicant: Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteo Compression Condyle Screw System is a distal fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur: Intercondylar fractures, Supracondylar fractures, and Unicondylar fractures.

Device Story

Distal femoral fracture fixation system; includes compression condyle plates, lag screws, and compression screws. Plates feature 95° barrel angle; accommodate 4.5mm cortical screws and 6.5mm cancellous screws. Lag screws are cannulated for guide wire use. System provides internal fixation to aid bone healing. Used in clinical/surgical settings by orthopedic surgeons. Provides stable fixation for fracture management; reduces soft tissue irritation.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate.

Technological Characteristics

Materials: ASTM F-138 Stainless Steel (Grade 2, 316LVM). Components: Compression condyle plates (95° barrel angle), lag screws (cannulated, 12.5mm diameter), and compression screws. Plates available in 6, 8, 10, 12 hole configurations. Non-sterile and sterile options.

Indications for Use

Indicated for patients with distal femur fractures, specifically intercondylar, supracondylar, and unicondylar fractures.

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.

Predicate Devices

• Synthes Dynamic Condylar Screw System

Submission Summary (Full Text)

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K971321 । of 2

Osteo Compression Condyle Screw System

510(k) Premarket Notification

# 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO COMPRESSION CONDYLE SCREW SYSTEM

JUL - 9 1997

# Submission Information

Name and Address of the Sponsor Osteonics Corporation of the 510(k) Submission: 59 Route 17 Allendale, NJ 07401-1677 201-825-4900 Donna S. Wilson Contact Person: Regulatory Affairs Specialist April 9, 1997 Date Summary Prepared: Device Identification Osteo Compression Condyle Screw System Proprietary Name: Compression Condyle Plate and Screw Common Name: Single/Multiple Component Metallic Bone Classification Name and Reference: Fixation Appliances and Accessories 21 CFR §888.3030

#### Predicate Device Identification

The Osteo Compression Condyle Screw System is substantially equivalent to the Synthes® Dynamic Condylar Screw System.

## Device Description

The Osteo Compression Condyle Screw System is a distal femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues.

## Osteo Compression Condyle Plates:

The Osteo Compression Condyle Plates are part of the Osteo Compression Condyle Screw System. These plates are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile. The Osteo Compression Condyle Plates are available in four (4) sizes with varying lengths and number of screw holes (6, 8, 10, and 12) for varied clinical situations. All plates have a 25mm barrel length and autocompression holes for cortical

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#### Osteo Compression Condyle Screw System

screws with a 4.5mm diameter. The two screw holes closest to the barrel also accommodate cancellous screws with a 6.5mm diameter. The plates feature a 95° barrel angle. The barrel slides over the inserted lag screw; a compression screw may be used for additional compression of the fracture area.

#### Osteo Lag Screws:

The Osteo Lag Screws which are the included as part of this premarket notification are available in three lengths (50mm, 55mm, and 60mm). Osteo Lag Screws of longer lengths, up to 145mm, have been cleared under a previous premarket notification. The subject Osteo Lag Screws are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile and sterile. All lag screws have a 22mm thread length for maximum purchase, a thread diameter of 12.5mm, and a cannulated end for ease of use with guide instrumentation.

#### Intended Use

The Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur: Intercondylar fractures, Supracondylar fractures, and Unicondylar fractures.

## Statement of Technological Comparison

The subject Osteo Compression Condyle Screw System components (compression condyle plates and lag screws) are substantially equivalent in design, materials, and intended use to the predicate devices offered by Synthes in their Dynamic Condylar Screw System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Donna S. Wilson Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

JUL - 9 1997

Re : K971321 Osteo Compression Condyle Screw System Regulatory Class: II Product Codes: HRS and HWC Dated: April 9, 1997 Received: April 10, 1997

Dear Ms. Wilson:

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 aqainst 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 Requlations, 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 requlation (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 requlation 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 requlations.

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Page 2 - Ms. Donna S. Wilson

This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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 requlation (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,

la 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) Number (if known): K 9 7 i 32 l

### Device Name: Osteo Compression Condyle Screw System

# Indications For Use:

-

The Osteo Compression Condyle Screw System-is a distal fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur:

- Intercondylar fractures .
- . Supracondylar fractures
- . Unicondylar fractures

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division | |
|---------------|---------------------|
| Division | testorative Devices |
| 510(k) Number | K971321 |

| Prescription Use | X | OR | Over-The-Counter Use |
|----------------------|---|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

(Optional Format 1-2-96)