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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for the Osteo Compression Condyle Screw System. It seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance acceptance criteria through a clinical study. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics, sample sizes, expert ground truth, and statistical effectiveness studies is not available or applicable in this type of submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, and the same or similar technological characteristics to the predicate device, or that any differences do not raise new questions of safety and effectiveness.
Reported Device Performance: The document states: "The Osteo Compression Condyle Screw System is substantially equivalent to the Synthes® Dynamic Condylar Screw System."
- Technological Comparison: The submission explicitly states, "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."
- Materials: Both the Osteo Compression Condyle Plates and Osteo Lag Screws are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM). This is a common, well-established material for implants.
- Design Characteristics: Specific dimensions and features are provided for the plates (e.g., 25mm barrel length, autocompression holes for 4.5mm cortical screws, 95° barrel angle) and lag screws (e.g., 22mm thread length, 12.5mm thread diameter, cannulated end). The implication is that these design characteristics are comparable to the predicate device.
- Intended Use: The intended uses for distal femoral fractures (Intercondylar, Supracondylar, Unicondylar) are listed and are presumed to be the same as or very similar to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission is based on demonstrating substantial equivalence through a comparison of design, materials, and intended use to a predicate device, not through a clinical performance study with a "test set" of patients or data in the way a diagnostic AI device would. No patient data or clinical study results are presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. See point 2.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical surgical implant, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is the established safety and effectiveness of the predicate device (Synthes® Dynamic Condylar Screw System), which has been legally marketed. The submission's goal is to show the new device is sufficiently similar to that known safe and effective predicate.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device requiring a training set. The "training" for such a device would be the extensive engineering and material science knowledge applied during its design and manufacturing, based on existing standards and predicate devices.

9. How the ground truth for the training set was established

Not applicable. See point 8.

In summary, this 510(k) submission is focused on demonstrating substantial equivalence to an existing device rather than presenting a clinical study to prove novel performance criteria. The "acceptance criteria" revolve around matching the characteristics and intended use of the legally marketed predicate device, and the "study" is primarily the detailed technical comparison provided within the submission itself.

Summary

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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

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.