Airlock Centrolock Osteosynthesis Implant System
Device Facts
| Record ID | K192356 |
|---|---|
| Device Name | Airlock Centrolock Osteosynthesis Implant System |
| Applicant | Novastep |
| Product Code | HRS · Orthopedic |
| Decision Date | Dec 14, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes. Examples include: Mono or Bi-Cortical osteotomies in the foot or hand Distal or Proximal metatarsal or metacarpal osteotomies Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) Calcaneus/cuboid arthrodesis Talar/navicular arthrodesis The system may be used in adult patients.
Device Story
Airlock® Centrolock® is a single-use metallic bone fixation system; consists of plates and screws for small bone surgery. Implants are manufactured from Titanium alloy (Ti-6Al-4V ELI). System utilizes 2mm cortical screws or 2.5mm locking screws; drill holes are aligned to prevent screw conflict. Used by surgeons in clinical settings for fracture fixation, osteotomies, and arthrodesis. Provides mechanical stabilization of bone segments to facilitate healing. Output is physical fixation of bone; aids clinical decision-making by providing structural support for bone reconstruction.
Clinical Evidence
Bench testing only. No clinical or animal studies were required for this submission. Mechanical performance validated via ASTM F382-17 (bending resistance) and ASTM F543-17 (pull-out strength, torsional resistance). Biocompatibility evaluated per ISO 10993-1.
Technological Characteristics
Materials: Wrought Titanium 6-Aluminium 4-Vanadium Alloy (ISO 5832-3). Components: Plates and screws (2mm cortical, 2.5mm locking). Standards: ASTM F382-17 (bending), ASTM F543-17 (pull-out/torsion). Connectivity: None (mechanical implant). Sterilization: Not specified.
Indications for Use
Indicated for adult patients requiring fixation and stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in hands, feet, ankles, fingers, and toes, including osteotomies and arthrodesis.
Regulatory Classification
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.
Predicate Devices
- Mini MaxLock Extreme® Plating System (K120157)
- MICA™ Screw System (K162353)
Reference Devices
- Airlock® Osteosynthesis Plate System (K143523)
Related Devices
- K143523 — Airlock osteosynthesis plate system · Novastep · Apr 6, 2015
- K151277 — Airlock® osteosynthesis plate system · Novastep · Aug 13, 2015
- K181843 — MLP Special Locking Bone Plate System · Maxxion Medical, LLC / Baumer SA · Mar 4, 2019
- K111253 — ARTHREX DISTAL EXTREMITY PLATE SYSTEM · Arthrex, Inc. · Aug 2, 2011
- K101962 — MINI MAXLOCK EXTREME PLATING SYSTEM · Orthohelix Surgical Designs, Inc. · Sep 27, 2010
Submission Summary (Full Text)
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December 14, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Novastep Gilles Audic QA/RA Director Espace Performance III- Batiment P Saint-Gregoire, 35769 FR
Re: K192356
Trade/Device Name: Airlock Centrolock Osteosynthesis Implant 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 Dated: August 19, 2019 Received: August 29, 2019
Dear Gilles Audic:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------------|----------------------------------------------------|
| Food and Drug Administration | |
| | Form Approved: OMB No. 0910-0120 |
| | Expiration Date: 06/30/2020 |
| | See PRA Statement below. |
| 510(k) Number (if known) | K192356 |
| Device Name | Airlock® Centrolock® osteosynthesis implant system |
**Indications for Use (Describe)**
Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes.
Examples include:
- Mono or Bi-Cortical osteotomies in the foot or hand
- Distal or Proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Calcaneus/cuboid arthrodesis
- Talar/navicular arthrodesis
The system may be used in adult patients.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <span> <label><input checked="checked" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> | <span> <label><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> |
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# tep®
#### "510(k) Summary" as required by section 807.92(c)
| Submitter | NOVASTEP |
|------------------|-----------------------------------------|
| | Espace performance 3 |
| | Bâtiment P |
| | 35769 SAINT GREGOIRE CEDEX |
| | France |
| | Phone: +33 (0)2 99 33 86 50 |
| | Fax: +33 (0)9 70 29 18 95 |
| Contact person | Mister Gilles AUDIC |
| | QA / RA Director |
| | Cell phone:+33 (0)6 30 93 96 08 |
| | e-mail: gilles.audic@novastep-ortho.com |
| Preparation date | December 13 2019 |
| Trade name | Airlock® Centrolock® osteosynthesis implant system |
|---------------------|---------------------------------------------------------------------------------------------------------------------|
| Common Name | Plate, Fixation, Bone |
| Classification Name | Single / Multiple component metallic bone fixation appliances and<br>accessories (21CFR 888.3030, product code HRS) |
| Regulatory class | II |
| Legally marketed<br>predicate devices | Primary predicate device<br>510(k) number: K120157<br>Device name: Mini MaxLock Extreme® Plating System<br>Original applicant: OrthoHelix Surgical Designs, Inc. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Reference device |
| | 510(k) number: K143523 |
| | Device name: Airlock® Osteosynthesis Plate System |
| | Original applicant: NOVASTEP. |
| | Other predicate |
| | 510(k) number: K162353 |
| | Device name: MICA™ Screw System |
| | Original applicant: Wright Medical Technology, Inc.. |
| Description | Airlock® Centrolock® osteosynthesis implant systems are single-use bone<br>fixation devices intended to be permanently implanted. implant systems<br>are designed with different shapes and are made of Titanium (Alloy Ti-<br>6Al-4V ELI).<br>The system uses either 2mm cortical screws or 2,5mm locking screws.<br>The drill holes are aligned to make sure there is no risk of conflict between<br>the screws.<br>The implant vary essentially through different curvatures and shapes. |
| Intended use | Airlock® Centrolock® osteosynthesis implant systems are single-use<br>devices intended for fixation and stabilization of fresh fractures,<br>revision procedures, joint fusion and reconstruction of small bones of<br>the hands, feet, ankle, fingers and toes.<br>Examples include: |
| | • Mono or Bi-Cortical osteotomies in the foot or hand |
| | • Distal or Proximal metatarsal or metacarpal osteotomies |
| | • Fixation of osteotomies for Hallux Valgus treatment (such as Scarf,<br>Chevron, etc.) |
| | • Calcaneus/cuboid arthrodesis |
| | • Talar/navicular arthrodesis |
| | The system may be used in adult patients. |
| Comparison of the<br>technological | The new devices Airlock® Centrolock® osteosynthesis implant system<br>implants have similar technological characteristics in terms of design<br>and mechanical characteristics [Static and dynamic bending resistance |
| characteristics with the<br>predicate device | (ASTM-F382-17) and thus are believed to be substantially equivalent to<br>the predicate Novastep Airlock® osteosynthesis Plate System.<br>The new devices Airlock® Centrolock® osteosynthesis implant system<br>screws have similar technological characteristics in terms of design and<br>mechanical characteristics (pull-out strength, torsional resistance<br>(ASTMF543-17 sections A1 A3) and thus are believed to be<br>substantially equivalent to the predicate Novastep Airlock®<br>osteosynthesis Plate System. |
| Performance data | The biocompatibility evaluation for new devices Airlock® Centrolock®<br>osteosynthesis implant systems was conducted in accordance with Blue<br>Book Memorandum #G95-1 "Use of International Standard ISO-10993,<br>'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'"<br>and International Standard ISO 10993-1 "Biological Evaluation of Medical<br>Devices - Part 1: Evaluation and Testing Within a Risk Management<br>Process" as recognized by FDA. |
| | The new devices Airlock® Centrolock® osteosynthesis implant system<br>implants have similar technological characteristics in terms of material<br>(ISO 5832-3 Fourth edition 2016-10-15 Implants For Surgery - Metallic<br>Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy)<br>and thus are believed to be substantially equivalent to the primary<br>predicate legally marketed device OrthoHelix Surgical Designs Mini<br>MaxLock Extreme® Plating System (K120157), and the reference device<br>marketed Novastep Airlock® osteosynthesis Plate System (K143523). |
| | The new devices Airlock® Centrolock® osteosynthesis implant system<br>screws have similar technological characteristics in terms of material (ISO<br>5832-3 Fourth edition 2016-10-15 Implants For Surgery - Metallic<br>Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy)<br>and thus are believed to be substantially equivalent to the primary<br>predicate legally marketed device OrthoHelix Surgical Designs Mini<br>MaxLock Extreme® Plating System (K120157), and the reference device<br>marketed Novastep Airlock® osteosynthesis Plate System (K143523). |
| Indication for use | Airlock® Centrolock® osteosynthesis implant systems are single-use<br>devices intended for fixation and stabilization of fresh fractures,<br>revision procedures, joint fusion and reconstruction of small bones of<br>the hands, feet, ankle, fingers and toes.<br>Examples include:<br>• Mono or Bi-Cortical osteotomies in the foot or hand<br>• Distal or Proximal metatarsal or metacarpal osteotomies<br>• Fixation of osteotomies for Hallux Valgus treatment (such as Scarf,<br>Chevron, etc.) |
| | • Calcaneus/cuboid arthrodesis<br>• Talar/navicular arthrodesis<br>The system may be used in adult patients. |
| Clinical studies | Clinical studies were not required for this submission |
| Animal Study | Animal Study was not required for this submission |
| Conclusion | The Airlock® Centrolock® osteosynthesis implant systems are<br>substantially equivalent to the primary predicate device OrthoHelix<br>surgical designs Mini MaxLock Extreme® Plating System (K120157), to the<br>reference Novastep Airlock® osteosynthesis plate systems (K143523), and<br>to the other predicate Wright Medical Technology MICA™ Screw System<br>(K162353) in terms of intended use and indications for use.<br>The Airlock® Centrolock® osteosynthesis implant systems are<br>substantially equivalent to the primary predicate device OrthoHelix<br>surgical designs Mini MaxLock Extreme® Plating System (K120157), to the<br>reference Novastep Airlock® osteosynthesis plate systems (K143523) in<br>terms of material, design and function. |
| | Any minor differences between these devices do not raise new questions<br>of safety and effectiveness. |
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