The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTIS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The design of the self-tapping OTIS-C Plus screws (unmodified) allows easy and reliable one step locking, without counter-nut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.

AI/ML Overview

This 510(k) submission describes a medical device, not a diagnostic AI/ML device. Therefore, the questions related to AI/ML specific performance criteria, ground truth, and expert evaluation are not applicable.

Here's an analysis of the provided text in the context of device acceptance criteria and study information:

Device Acceptance Criteria and Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The criteria are implicitly derived from the established safety and effectiveness of the predicate.

Acceptance Criteria	Reported Device Performance
Fretting Corrosion (comparable to predicate)	Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices.
Torsional Yield Strength (comparable to predicate)	Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices.
Ultimate Torque (comparable to predicate)	Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices.
Insertion Torque (comparable to predicate)	Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices.
Removal Torque (comparable to predicate)	Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices.
Pull-Out Strength (comparable to predicate)	Demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices.
Mechanical Behavior (unchanged by modification)	Finite Element Method demonstrates that modification to OTIS-C Plus plate do not alter its mechanical behavior.
Fretting Corrosion (unchanged by modification)	Finite Element Method demonstrates that modification to OTIS-C Plus plate do not alter its fretting corrosion.

Study Description:

Sample size used for the test set and the data provenance: Not explicitly stated as this is a non-clinical, mechanical testing study. The "test set" would refer to the physical samples of the OTIS-C Plus device and its components used for the performance testing. The provenance of the data is from SCIENCE FOR BIOMATERIALS, a French company. The study is prospective in the sense that the testing was performed on the newly designed modified device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical engineering study, not an imaging or diagnostic study requiring expert interpretation for ground truth. The "ground truth" is established by the physical laws and engineering principles governing the materials and their interactions.
Adjudication method for the test set: Not applicable. This refers to consensus methods for expert opinions, which is not relevant for mechanical testing.
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 is not an AI/ML device or a diagnostic device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used: For the mechanical performance tests (fretting corrosion, torsional yield strength, etc.), the "ground truth" is the established scientific and engineering principles for material properties and device performance under specified conditions, as measured by standard laboratory tests. For the Finite Element Method (FEM) analysis, the "ground truth" or reference for comparison is the mechanical behavior and fretting corrosion of the predicate device (K100604).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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K120818

APR 1 9 2012

510(k) SUMMARY

As required by section 807.92

Submitter	SCIENCE FOR BIOMATERIALSSciences et Bio MatériauxZI du MongeF 65100 LOURDES - FRANCERegistration Number : 3004549189
Contacts	Denis CLEMENT, CEOTel : +33 (0)5 62 42 21 01Fax : +33 (0)5 62 42 21 00e-mail : denis.clement@sbm-fr.comRegulatory contact: Idée Consulting (FRANCE)Isabelle DRUBAIX e-mail : idrubaix@nordnet.fr
Trade Name	OTIS-C Plus
510k	SPECIAL 510K
CFR section	21CFR 888.3030
Classification Name	Single/multiple component metallic bone fixation appliancesand accessories
Class	II.
Product Codes	HRS: PLATE, FIXATION, BONEHWC : SCREW, FIXATION, BONE
Device panel	ORTHOPEDIC
Legally marketed predicate devices	OTIS-C PLUS (K100604 manufactured by SCIENCE FORBIOMATERIALS

Description: The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTIS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The design of the self-tapping OTIS-C Plus screws (unmodified) allows easy and reliable one step locking, without counter-nut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.

Intended Use OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies

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Image /page/1/Picture/0 description: The image contains handwritten text that appears to be a combination of letters and numbers. The text reads 'KI20818#a/2'. The characters are written in black ink on a white background. The handwriting is somewhat stylized, with distinct shapes for each character.

Performance data Non clinical performance testing including fretting corrosion, and determination of torsional yield strength, ultimate, insertion and removal torque and pull-out strength demonstrated that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices. Finite Element Method demonstrates that modification to OTIS-C Plus plate do not alter its mechanical behavior or fretting corrosion. No clinical data has been presented.

Substantial equivalence The modified OTIS-C plus plate is substantially equivalent to its predicate device OTIS-C plus plate (K100604). Verification activity and validation activity demonstrate that modified OTIS-C plus plate is as safe, as effective, and performs at least as safely and effectively as its predicate devices.

Preparation date, revised April 19th 2012

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Science for Biomaterials Science et Bio Materiaux (SMB) % Mr. Denis Clement ZI du Monge Lourdes France F 65100

APR 1 9 2012

Re: K120818

Trade/Device Name: OTIS-C Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II

Product Code: HRS, HWC Dated: March 16, 2012 Received: March 22, 2012

Dear Mr. Clement:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 r loase of acressed 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 urry I vatuall the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 -- Mr. Denis Clement

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

FOR Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) OTIS-C Plus

SBM
Science & Bio Materials

INDICATIONS FOR USE

510(k) Number (if known): K120818

Device Name: OTIS-C Plus

Indications for Use:

OTIS-C Plus 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)	AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120618

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.