(125 days)
Not Found
No
The summary describes a mechanical bone plate and fixation system with no mention of software, algorithms, or AI/ML terms.
Yes
The device is a plate used to fix bone following osteotomies, which is a surgical procedure to correct conditions or deformities, hence it is therapeutic.
No
The device is described as a plate used for fixation following osteotomies and is a surgical implant, not a diagnostic tool.
No
The device description clearly describes a physical bone plate and associated screws and pins, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- NEOTIS Plate Function: The NEOTIS Plate is a surgical implant designed to provide mechanical fixation of bone following a specific surgical procedure (proximal tibial opening wedge osteotomy). It is used in the body, not to test samples from the body.
- Intended Use: The intended use clearly states it's for "fixation following Proximal Tibial Opening wedge osteotomies," which is a surgical intervention.
- Device Description: The description details a physical plate and screws used for bone stabilization.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, based on the provided information, the NEOTIS Plate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NEOTIS Plate is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The NEOTIS plate is designed for medial approach High Tibial Osteotomy stabilization. Anatomically shaped, thin and short, the NEOTIS plate enables minimally invasive surgery. The changes brought by the NEOTIS plate are as follows (vs. OTIS-C Plus plate):
- The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced.
- The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws).
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)
The mechanical properties are the same as for the previous OTIS-C Plus, the only changes occur during the placement of the plate. No clinical data has been presented. Non-clinical performance testing includes a cadaver study that confirms the level of compression induced during the placement of the plate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Traditional 510(k) NEOTIS System
Image /page/0/Picture/1 description: The image shows the letters SBM in bold, black font. Below the letters is the phrase "Science & Bio Materials" in a smaller font. To the right of the letters are three right-pointing triangles. The first triangle is gray, the second is black, and the third is white.
・
K140226 page 1 of 2
JUN 0 3 2014
.
510(k) SUMMARY
As required by section 807.92
.
1. GENERAL INFORMATION
· .
| Type of 510(k) | TRADITIONAL |
|---|---|
| Trade Name | NEOTIS Plate and Screws |
| 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 | K100604 and K120818 OTIS-C Plus® Plate Fixation System |
| manufactured by SBM Sciences for Bio Materials. | |
| 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 : Anne COSPIN-LATAPIE | |
| anne.cospin@sbm-fr.com |
1
Traditional 510(k) NEOTIS System
K140226 page 2 of 2
2. DEVICE DESCRIPTION
The NEOTIS plate is designed for medial approach High Tibial Osteotomy stabilization. Anatomically shaped, thin and short, the NEOTIS plate enables minimally invasive surgery. The changes brought by the NEOTIS plate are as follows (vs. OTIS-C Plus plate):
-
The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced.
-
The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws).
3. INDICATIONS FOR USE
NEOTIS plate is intended to be used in conjunction with OTIS screws to provide fixation following Proximal Tibial opening wedge osteotomies.
4. PERFORMANCE DATA ·
The mechanical properties are the same as for the previous OTIS-C Plus, the only changes occur during the placement of the plate. No clinical data has been presented. Non-clinical performance testing includes a cadaver study that confirms the level of compression induced during the placement of the plate.
5. SUBSTANTIAL EQUIVALENCE
The NEOTIS plate is substantially equivalent to its predicate device OTIS-C Plus plate (K100604 and K120818). Verification and validation tests demonstrate that modified the NEOTIS plate is as safe, as effective, and performs as safely and effectively as its predicate device.
Summary preparation date: June 2, 2014
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2014
Science for Biomaterials (Sciences et Bio Matériaux) Mr. Denis Clement General Manager ZI du Monge F 65100 Lourdes - FRANCE
Re: K140226
Trade/Device Name: NEOTIS Plate and Screws 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: April 11, 2014 Received: April 14, 2014
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 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
3
Page 2 - Mr. Denis Clement
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k) NEOTIS Plate
SBM
INDICATIONS FOR USE
510(k) Number (if known): K140226 Device Name: NEOTIS Plate and Screws Indications for Use:
NEOTIS Plate is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.
AND/OR
Prescription Use く (Part 21 CFR 801 Subpart D)
.
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)
Elizabet标验厂rank -S
Division of Orthopedic Devices