(103 days)
Not Found
No
The summary describes a mechanical orthopedic implant and its associated screws, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
This device is a medical implant designed to provide stable fixation of bone following an osteotomy, which is a therapeutic intervention.
No
The device is described as a plate and screws used for fixation following osteotomies, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly describes a physical plate and screws intended for surgical implantation, which are hardware components.
Based on the provided information, 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 within the body for structural support.
- Device Description: The description details a "plate" and "screws" designed for "stabilization of High Tibial Osteotomy." This further reinforces its role as a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information contains none of these characteristics.
Therefore, the OTIS-C Plus is a surgical implant, not an In Vitro Diagnostic device.
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 OTTS-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 selftapping OTIS-C Plus screws allows easy and reliable one step locking, without counternut, 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, High 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 demonstrate that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices.
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
K100604#1/6
510(k) OTIS-C Plus
SB
510(k) Summary
As required by section 807.92
JUN 1 4 2010
1. GENERAL INFORMATION
| Type of 510(k) | TRADITIONAL |
|---|---|
| Trade Name | OTIS-C Plus |
| CFR section | 21CFR 888.3030 |
| Classification Name | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Device panel | ORTHOPEDIC |
| Product Code | HRS: PLATE, FIXATION, BONE |
| HWC : SCREW, FIXATION, BONE | |
| Class | II |
| Legally marketed | |
| predicate devices | K041709 NUMELOCK II SYSTEM manufactured by |
| HOWMEDICA OSTEONICS CORP (now STRYKER | |
| ORTHOPAEDICS) and K973812 ARTHREX PUDDU | |
| OSTEOTOMY SYSTEM manufactured by ARTHREX, INC. | |
| Submitter | SCIENCE FOR BIOMATERIALS |
| Sciences et Bio Matériaux | |
| ZI du Monge | |
| F 65100 LOURDES - FRANCE | |
| Registration Number : 3004549189 | |
| Contact | 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 |
.
1
510(k) OTIS-C Plus
2. 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 OTTS-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 selftapping OTIS-C Plus screws allows easy and reliable one step locking, without counternut, 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.
3. 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.
4. SUBSTANTIAL EQUIVALENCE
Both OTIS-C Plus system and its predicates are plate and screw systems made of stainless steel. Plates included in all these systems present 4 holes. Both OTIS-C Plus system and its predicate NUMELOCK II SYSTEM include screw 6.5 mm in diameter and plate 3 mm thick. Both plates and screws are supplied in a similar range of length.
Non clinical performance testing including fretting corrosion, and determination of torsional yield strength, ultimate, insertion and removal torque and Pull-out strength demonstrate that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices.
Summary preparation date: revised May 31, 2010
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Science Et Bio Materiaux (SMB) % Mr. Denis Clement Zi du Monge Lourdes France 65100
JUN 1 4 2010
Re: K100604 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: II Product Code: HRS, HWC Dated: June 01, 2010 Received: June 03, 2010
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 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
3
Page 2 - Mr. Denis Clement
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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.goy/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N Milliken
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
INDICATIONS FOR USE
510(k) Number (if known): K100604 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)
Smith for nxa
and Restorative Devic
510(k) Number K100604
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