(275 days)
Not Found
No
The device description and intended use are solely focused on mechanical implants (plates and screws) for fracture fixation and fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a titanium plate and screw system intended for internal fracture fixation and fusion, which are therapeutic interventions.
No
The device is described as a titanium plate and screw system intended for internal fracture fixation and fusion of ankle bones. Its purpose is to repair and stabilize damaged skeletal structures, not to diagnose medical conditions.
No
The device description explicitly states it is a "titanium plate and screw system," 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 is for "skeletal osteosynthesis of small bone fragments," "primary or revision tibio-talar and tibiotalo-calcaneal fusion," and "post-traumatic surgery." These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as "titanium plate and screw systems intended for internal fracture fixation of the ankle." This is a surgical implant.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is a surgical implant used for internal fixation, which is a completely different category from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ANKLE FIX and ANKLE FIX + System 4.0 are intended to support normal bone healing for osteotomies, fractures and reconstruction. The systems are indicated for: skeletal osteosynthesis of small bone fragments, which were damaged due to trauma or require reconstruction or arthrodesis primary or revision tibio-talar and . tibiotalo-calcaneal fusion especially in the presence of osteopenic bone. hindfoot deformity and bone loss post-traumatic surgery.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Normed ANKLE FIX and ANKLE FIX + Systems 4.0 are titanium plate and screw systems intended for internal fracture fixation of the ankle. The pre-contoured plates are anatomically designed for optimal screw positioning. This trauma system offers lateral plates for fusion of the tibiotalar (ANKLE FIX) and tibiotalo-calcaneal (ANGLE FIX +) bones as well as medial, posterior (hindfoot), posterior tibia and anterior plates as needed for the ankle for stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, tibiotalar, tibiotalo-calcaneal, hindfoot
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 testing demonstrated for the Normed ANKLE FIX and ANKLE FIX + Systems 4.0 meets performance requirements as defined by Design Control activities and are substantially equivalent to the predicate devices in terms of safety and efficacy.
Plates: Static and dynamic 4 point bending tests were performed on the worst case. Standard: ASTM 382-99.
Screws: Torsional properties, driving torque, and axial pull-out strength tests were performed on the worst case. Standard: ASTM F543-07.
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
510(k) Summary Pursuant to 21 CFR 807.92
General Company Information
| Company Name: | Normed® Medizin-Technik GmbH | |
|---|---|---|
| Company Address: | Ulrichstrasse 7 | |
| D-78532 | ||
| Tuttlingen, Germany | ||
| Company Telephone: | + (011) 49 7461 93 43 0 |
- (011) 49 7461 93 43 20 | |
| Contact: | David Furr, MS
FDC Services, LLC
US Agent | AUG 0 2 2013 |
| Contact Address: | 8708 Capehart Cove
Austin, Texas 78733
(512) 906-9654 | |
| Date: | August 2, 2013 | |
| Device Trade Name: | Normed® ANKLE FIX and ANKLE FIX +
Systems 4.0 | |
| Common Name: | bone plates and bone screws | |
| Classification Name
and Reference: | HRS- 888.3030, single/multiple component
metallic bone fixation appliances and
accessories
HWC-888.3040, Smooth or threaded,
metallic bone fixation fastener | |
| Predicate Device: | Normed Titanium Calcaneus Plating with
Locking Screw System - K022324, cleared
9/17/02 | |
1
510(k) Premarket Notification Normed ANKLE FIX System and Normed ANKLE FIX Plus System 4.0 VLP Foot Talus and Percutaneous Calcaneus Bone Plates, VLP Bone Screws: Peri-Loc Ankle Fusion Bone Plates and Instruments - K110670, cleared 7/12/11 Ascension Ankle Fusion Plate System -K100176, cleared 6/16/10 Device Description: The Normed ANKLE FIX and ANKLE FIX + Systems 4.0 are titanium plate and screw systems intended for internal fracture fixation of the ankle. The pre-contoured plates are anatomically designed for optimal screw positioning. This trauma system offers lateral plates for fusion of the tibiotalar (ANKLE FIX) and tibiotalo-calcaneal (ANGLE FIX +) bones as well as medial, posterior (hindfoot), posterior tibia and anterior plates as needed for the ankle for stability. Intended Use: The ANKLE FIX and ANKLE FIX + System 4.0 are intended to support normal bone healing for osteotomies, fractures and reconstruction. The systems are indicated for: skeletal osteosynthesis of small bone . fragments, which were damaged due to trauma or require reconstruction or arthrodesis primary or revision tibio-talar and . tibiotalo-calcaneal fusion especially in the presence of osteopenic bone. hindfoot deformity and bone loss post-traumatic surgery.
2
510(k) Premarket Notification Normed ANKLE FIX System and Normed ANKLE FIX Plus System 4.0
| Testing and Technological | |
|---|---|
| Characteristics: | The technological characteristics of this |
| ankle system are similar to its predicates by | |
| having the similar intended use, material, | |
| lengths, thickness and overall design. | |
| The implants are provided sterile and non- | |
| sterile. They are for single use orthopaedic | |
| surgical application. The instruments are | |
| non-sterile and reusable. | |
| Non-clinical testing demonstrated for the | |
| Normed ANKLE FIX and ANKLE FIX + | |
| Systems 4.0 meets performance | |
| requirements as defined by Design | |
| Control activities and are substantially |
| Device | Testing | Standard |
|---|---|---|
| Plates | Static and dynamic 4 point bending tests were performed on the worst case | ASTM 382-99 |
| Screws | Torsional properties, driving torque, and axial pull-out strength tests were performed on the worst case | ASTM F543-07 |
equivalent to the predicate devices in terms
of safety and efficacy.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Normed® Medizin-Technik GmbH % FDC Services, LLC Mr. David C. Furr Principle Consultant, US Agent 8708 Capehart Cove Austin, Texas 78733
August 2, 2013
Re: K123347
Trade/Device Name: Normed® ANKLE FIX and ANKLE FIX PLUS Systems 4.0 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: June 18, 2013 Received: July 3, 2013
Dear Mr. Furr:
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
4
Page 2 - Mr. David C. Furr
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/McdicalDevices/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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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510(k) Premarket Notification Normed ANKLE FIX System 4.0 and Normed ANKLE FIX Plus System 4.0
Indications for Use Statement
K123347 510(k) Number:
Device Name: ANKLE FIX and ANKLE FIX Plus Systems 4.0
Indications For Use:
く
ANKLE FIX and ANKLE FIX + Systems 4.0 are indicated for:
- · skeletal osteosynthesis of small bone fragments, which were damaged due to trauma or require reconstruction or arthrodesis
- · primary or revision tibio-talar and tibiotalo-calcaneal fusion especially in the presence of osteopenic bone, hindfoot deformity and bone loss
- · post-traumatic surgery.
| Prescription Use | X |
|---|---|
| (per CFR 801.109) | |
| or | |
| Over-the-counter use |
Concurrence of CDRH
Elizabeth L. Frank -S
Division of Orthopedic Devices