(94 days)
The Activ Ankle Locking Plating System is intended for the fixation of fractures and pseudarthrosis of the distal and the diaphyseal fibula and for syndesmotic repair in adults.
The Activ Ankle Locking Plating System consists of a plate with many screws as holes (slots) designed for fixation of fractures, osteotomies and pseudarthrosis of the distal and diaphyseal fibula and for the syndesmotic repair in adults. The plates and screws are manufactured from titanium alloy and color anodized. Washers are also available for use with syndesmosis screws. The Activ Ankle Locking Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.
This document describes the 510(k) premarket notification for the "Activ Ankle Locking Plating System," a medical device, and therefore does not contain information about software or AI-enabled insights, acceptance criteria, or study results in the context of AI/ML performance.
The document discusses the device's intended use, materials, and mechanical testing results to demonstrate substantial equivalence to predicate devices, as required for FDA 510(k) clearance.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, ground truth establishment, or multi-reader multi-case studies because this document is about a bone fixation device and does not involve AI or clinical performance studies of an AI algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
NEWCLIP TECHNICS % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K143061
Trade/Device Name: Activ Ankle Locking Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 22, 2014 Received: October 24, 2014
Dear Mr. Webb:
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
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Page 2 - J.D. Webb
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143061
Device Name Activ Ankle Locking Plating System
Indications for Use (Describe)
The Activ Ankle Locking Plating System is intended for the fixation of fractures and pseudarthrosis of the distal and the diaphyseal fibula and for syndesmotic repair in adults
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510 (k) Summary for the Activ Ankle Locking Plating System 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Activ Ankle Locking Plating System.
Summary preparation date: January 26, 2015
| 1. Submitter: | Contact Person: | |
|---|---|---|
| NEWCLIP TECHNICS | J.D. Webb | |
| P.A. de la Lande Saint Martin | The OrthoMedix Group, Inc. | |
| 45 rue des Garottières | 1001 Oakwood Blvd | |
| F-44115 Haute-Goulaine - France | Round Rock, TX 78681 | |
| Telephone: (33) 2 28 21 37 12 | Telephone: 512-388-0199 | |
| 2. Trade name: | Activ Ankle Locking Plating System | |
| Common Name: | Plates for fibula fractures, osteotomies andpseudarthrosis | |
| Screws and washers associated | ||
| Instrumentation associated | ||
| Product code: | HRS/HWC | |
| Classification Name: | Plate, Fixation, Bone | |
| (21 CFR part. 888.3030) | ||
| Screw, Fixation, Bone | ||
| (21 CFR part. 888.3040) |
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3. Predicate or legally marketed devices which are substantially equivalent:
- The Synthes Small Fragment Dynamic Compression Locking (DCL) System . of Synthes (K000684),
- The Synthes 2.7mm/3.5mm LCP Distal Fibula Plates of Synthes (K073460), .
- The Ortholoc® 3Di Ankle Plating System of Wright Medical Technology, . Inc. (K131093),
- The Synthes Variable Angle LCP Ankle Trauma System (K120854). •
| 4. Description of the device: | The Activ Ankle Locking Plating Systemconsists of a plate with many screws asholes (slots) designed for fixation offractures, osteotomies and pseudarthrosisof the distal and diaphyseal fibula and forthe syndesmotic repair in adults. The platesand screws are manufactured fromtitanium alloy and color anodized.Washers are also available for use withsyndesmosis screws. |
|---|---|
| The Activ Ankle Locking Plating Systemwill be provided non sterile forsterilization by health care professionalsprior to use or provided sterile by gammasterilization. | |
| Materials: | Titanium alloy Ti-6Al-4V ELI (conform toASTM F 136-12a and/or ISO 5832-3). |
| Function: | The implants of the Activ Ankle LockingPlating System are indicated for fixation offractures, osteotomies and pseudarthrosisof the distal and the diaphyseal fibula inadults. |
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5. Substantial equivalence claimed to predicate devices:
The Activ Ankle Locking Plating System is substantially equivalent to the Synthes Small Fragment Dynamic Compression Locking (DCL) System of Synthes (K000684), the Ortholoc® 3Di Ankle Plating System from Wright Medical Technology, Inc. (K131093), the Synthes 2.7mm/3.5mm LCP Distal Fibula Plates of Synthes (K073460), and The Synthes Variable Angle LCP Ankle Trauma System (K120854) in terms of intended use, design, materials used, mechanical safety and performance.
6. Intended use:
The Activ Ankle Locking Plating System is indicated for fixation of fractures, osteotomies and pseudarthrosis of the distal and diaphyseal fibula and for the syndesmotic repair in adults.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative fatigue compression tests. .
- Comparative static tests. .
- Geometric analysis of the subject and predicate screws .
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
The Activ Ankle Locking Plating System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
§ 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.