(31 days)
Not Found
No
The summary describes a bone plate and screw system for surgical fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a bone plate and screw system intended for fixation after an osteotomy, which is a surgical procedure to correct deformities or pain. This falls under the definition of a therapeutic device as it directly treats a medical condition by providing fixation and stabilization.
No
This device is a plate meant for fixation following osteotomies, which is a therapeutic device for stabilization, not a diagnostic one.
No
The device description clearly describes a physical plate and screws intended for surgical implantation, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used "in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies." This describes a surgical implant used to stabilize bone, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The description details a "plate" and "screws" designed for "stabilization of High Tibial Osteotomy." This further confirms it's a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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
Product codes
HRS, HWC
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal Tibial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
APR 1 9 2012
510(k) SUMMARY
As required by section 807.92
| Submitter | SCIENCE FOR BIOMATERIALS
Sciences et Bio Matériaux
ZI du Monge
F 65100 LOURDES - FRANCE
Registration Number : 3004549189 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Denis CLEMENT, CEO
Tel : +33 (0)5 62 42 21 01
Fax : +33 (0)5 62 42 21 00
e-mail : denis.clement@sbm-fr.com
Regulatory 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 appliances
and accessories |
| Class | II. |
| Product Codes | HRS: PLATE, FIXATION, BONE
HWC : SCREW, FIXATION, BONE |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | OTIS-C PLUS (K100604 manufactured by SCIENCE FOR
BIOMATERIALS |
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
1
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
2
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
3
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
4
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