The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.

Device Description

The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of a single tapered plate, screws (cancellous and cortical design), and spacer blocks in various sizes. The plate in this system accepts 6 mm cancellous screws proximally and 4.5 mm cortical screw distally. The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is manufactured from Titanium/Titanium Alloy and will be provided sterile.

AI/ML Overview

The provided document describes a 510(k) submission for the Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data detailing acceptance criteria and performance against those criteria as would be required for a novel device or a PMA.

Therefore, many of the requested details, particularly those related to a study proving the device meets specific performance acceptance criteria for an AI/algorithm-based medical device, a multi-reader multi-case (MRMC) study, or a standalone algorithm performance study, are not applicable and not present in this document. This document concerns a physical orthopedic implant system, not a software algorithm.

Here's a breakdown of the information that can be extracted and an explanation of the missing information based on the provided text:

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

Acceptance Criteria (Inferred)	Reported Device Performance
Substantial equivalence to predicate device (Arthrex Puddu Osteotomy System, K973812) in terms of safety and effectiveness.	Biomechanical testing of the subject device was found to be similar in performance to previously cleared high tibial osteotomy systems with similar indications. The FDA determined the device is substantially equivalent for the stated indications for use.
Similar technological characteristics to predicate.	Constructed from Titanium/Titanium Alloy. Consists of a single tapered plate, screws (cancellous and cortical design), and spacer blocks. Plate accepts 6 mm cancellous screws proximally and 4.5 mm cortical screws distally.
Intended Use	Used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies. This matches the inferred intended use of predicate devices based on the substantial equivalence claim.

Explanation: In a 510(k) submission for a physical device like this, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The performance is typically demonstrated through non-clinical testing (e.g., biomechanical testing) rather than clinical trials with specific clinical performance metrics.

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 / Not Provided. The document mentions "biomechanical testing" but does not specify sample sizes for test sets, data provenance, or whether it was a retrospective or prospective study. This type of detail is not typically required or included in a 510(k) summary for a mechanical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided. This concept (experts establishing ground truth for a test set) is primarily relevant to AI/diagnostic imaging devices. For a physical orthopedic implant, "ground truth" relates to material properties, mechanical performance, and surgical outcomes, which are assessed through engineering and clinical evaluations, not expert consensus on image interpretation.

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

Not Applicable / Not Provided. Adjudication methods are typically used in clinical trials or studies to resolve discrepancies in expert interpretations (e.g., of medical images). This is not relevant to the biomechanical testing of a bone plate system.

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

No. This is a physical medical device (bone plating system), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.

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

No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

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

Inferred based on "Biomechanical testing": The "ground truth" for this device would be established by engineering standards for mechanical strength, fatigue, fixation stability, and material biocompatibility. This would involve laboratory testing against established benchmarks or comparative data from the predicate device. It is not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic tools.

8. The sample size for the training set

Not Applicable / Not Provided. "Training set" refers to data used to train an AI model. This device is not an AI model. Mechanical and materials testing would involve specific sample sizes for tests such as ultimate tensile strength, fatigue life, etc., but these are not referred to as "training sets."

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

Not Applicable / Not Provided. As this is not an AI device, there is no "training set" or "ground truth for a training set" in that context.

Summary

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KOS0992

SEP - 4 2008

Page 1 of 1

510(k) SUMMARY (as required by 21 CFR 807.92)

High Tibial Osteotomy (HTO) Plating System April 7, 2008

COMPANY:	Aesculap Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Lisa M. Boyle(610) 984-9274 (phone)610-791-6882 (fax)
TRADE NAME:	HTO Plating System
COMMON NAME:	High Tibial Osteotomy (HTO) Plating System
CLASSIFICATION NAME:	Plate, Fixation, Bone (HRS)Screw, Fixation, Bone (HWC)

SUBSTANTIAL EQUIVALENCE

REGULATION NUMBER: 888.3030 / 888.3040

Aesculap Implant Systems, Inc., believes that the HTO Plating System is substantially equivalent to the Arthrex Puddu Osteotomy System (K973812).

DEVICE DESCRIPTION

INDICATIONS FOR USE

The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Implant Systems HTO Plating System is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing of the subject device was found to be similar in performance to previously cleared high tibial osteotomy systems with similar indications.

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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 features a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

SEP - 4 2008

Re: K080992

Trade/Device Name: High Tibial Osteotomy (HTO) Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 5, 2008 Received: August 5, 2008

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 - Ms. Lisa M. Boyle

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millman

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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A. INDICATIONS FOR USE STATEMENT

Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating Device Name:

System

Indications for Use:

The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brelund for npm

(Division of General, Restorative, and Neurological Devices

510(k) Number
K083094

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.