(109 days)
The Alians Ulna Locking Plating System is intended for ulnar shortening osteotomy.
The Alians Ulna Locking Plating system consists of a plate with many screws as holes (slots) designed for ulnar shortening osteotomy. The plates and screws are manufactured from titanium alloy and color anodized. The Alians Ulna Locking Plating system will be provided non-sterile for sterilization by health care professional's prior use.
This document is a 510(k) premarket notification for the "Alians Ulna Locking Plating System". It does not describe a study involving an AI/ML device that requires acceptance criteria. Instead, it describes a medical device (a plating system for bone fixation) and the non-clinical tests performed to demonstrate its substantial equivalence to previously marketed predicate devices.
Therefore, I cannot provide a response based on your request, as the provided input does not contain information about an AI/ML device study, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as outlined in your prompt.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
NEWCLIP TECHNICS % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K142502 Trade/Device Name: Alians Ulna Locking Plating System 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: October 3, 2014 Received: October 6, 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 (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
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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" (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,
Lori A. Wiggins -S
for 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) K142502
Device Name
ALIANS ULNA LOCKING PLATING SYSTEM
Indications for Use (Describe)
The Alians Ulna Locking Plating System is intended for ulnar shortening osteotomy.
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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4. 510 (k) Summary for the Alians Ulna Locking Plating System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Alians Ulna Locking Plating System.
Contact Person:
Summary preparation date: July 17, 2014
1. Submitter:
NEWCLIP TECHNICS J.D. Webb The OrthoMedix Group, Inc. P.A. de la Lande Saint Martin 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: | Alians Ulna Locking Plating System |
|---|---|
| Common Name: | Plates for ulna shortening osteotomyScrews 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 One-Third Tubular DCL Plate (K011335). .
- Newclip Radius Plates (K061917) .
- Newclip Clavicle Plate System (K100944) ●
- Newclip Distal Radius Plate (K130774) .
| 4. Description of the device: | The Alians Ulna Locking Plating systemconsists of a plate with many screws asholes (slots) designed for ulnar shorteningosteotomy. The plates and screws aremanufactured from titanium alloy andcolor anodized. |
|---|---|
| The Alians Ulna Locking Plating systemwill be provided non-sterile forsterilization by health care professional'sprior use. | |
| Materials: | Titanium alloy Ti-6Al-4V ELI (conform toASTM F 136-12a and/or ISO 5832-3). |
| Function: | The implants of the Alians Ulna LockingPlating System are indicated for fixation ofulnar shortening osteotomy. |
5. Substantial equivalence claimed to predicate devices:
The Alians Ulna Locking Plating System is substantially equivalent to Synthes One-Third Tubular DCL Plate (K011335), to the Newclip Radius Plates (K061917), to the Newclip Clavicle Plate System (K100944) and to the Newclip Distal Radius Plate (K130774) in terms of intended use, design, materials used, mechanical safety and/or performance.
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6. Intended use:
The Alians Ulna Locking Plating System is indicated for ulnar shortening osteotomy.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative fatigue compression tests on plates. .
- Comparative static tests on plates. .
- Pullout and torsional strength tests on screws. .
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
The Alians Ulna 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.