(107 days)
No
The device description and intended use focus on the physical characteristics and function of a bone fixation implant system, with no mention of AI or ML.
Yes
The device is intended for "fixation and stabilization of ... fractures, revision procedures, joint fusion and reconstruction," which are therapeutic purposes.
No
Explanation: The device is an osteosynthesis implant system intended for fixation and stabilization of fractures and other bone procedures, not for diagnosing conditions.
No
The device description explicitly states it is a "single-use bone fixation device intended to be permanently implanted" and is made of Titanium. This indicates a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
The provided text describes a surgical implant system used for fixing and stabilizing bones. IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is implanted directly into the body for structural support, which is not the function of an IVD.
N/A
Intended Use / Indications for 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.
Product codes
HRS
Device Description
Airlock® Centrolock® osteosynthesis implant systems are single-use bone fixation devices intended to be permanently implanted. implant systems are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 2mm cortical screws or 2,5mm locking screws. The drill holes are aligned to make sure there is no risk of conflict between the screws. The implant vary essentially through different curvatures and shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands, feet, ankle, fingers and toes
Indicated Patient Age Range
adult patients
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 biocompatibility evaluation for new devices Airlock® Centrolock® osteosynthesis implant systems was conducted in accordance with Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA.
The new devices Airlock® Centrolock® osteosynthesis implant system implants have similar technological characteristics in terms of material (ISO 5832-3 Fourth edition 2016-10-15 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy) and thus are believed to be substantially equivalent to the primary predicate legally marketed device OrthoHelix Surgical Designs Mini MaxLock Extreme® Plating System (K120157), and the reference device marketed Novastep Airlock® osteosynthesis Plate System (K143523).
The new devices Airlock® Centrolock® osteosynthesis implant system screws have similar technological characteristics in terms of material (ISO 5832-3 Fourth edition 2016-10-15 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy) and thus are believed to be substantially equivalent to the primary predicate legally marketed device OrthoHelix Surgical Designs Mini MaxLock Extreme® Plating System (K120157), and the reference device marketed Novastep Airlock® osteosynthesis Plate System (K143523).
Clinical studies were not required for this submission.
Animal Study was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
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 |
| accessories (21CFR 888.3030, product code HRS) | |
| Regulatory class | II |
| Legally marketed
predicate devices | Primary predicate device
510(k) number: K120157
Device name: Mini MaxLock Extreme® Plating System
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
fixation devices intended to be permanently implanted. implant systems
are designed with different shapes and are made of Titanium (Alloy Ti-
6Al-4V ELI).
The system uses either 2mm cortical screws or 2,5mm locking screws.
The drill holes are aligned to make sure there is no risk of conflict between
the screws.
The implant vary essentially through different curvatures and shapes. |
| 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. |
| Comparison of the
technological | The new devices Airlock® Centrolock® osteosynthesis implant system
implants have similar technological characteristics in terms of design
and mechanical characteristics [Static and dynamic bending resistance |
| characteristics with the
predicate device | (ASTM-F382-17) and thus are believed to be substantially equivalent to
the predicate Novastep Airlock® osteosynthesis Plate System.
The new devices Airlock® Centrolock® osteosynthesis implant system
screws have similar technological characteristics in terms of design and
mechanical characteristics (pull-out strength, torsional resistance
(ASTMF543-17 sections A1 A3) and thus are believed to be
substantially equivalent to the predicate Novastep Airlock®
osteosynthesis Plate System. |
| Performance data | The biocompatibility evaluation for new devices Airlock® Centrolock®
osteosynthesis implant systems was conducted in accordance with Blue
Book Memorandum #G95-1 "Use of International Standard ISO-10993,
'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'"
and International Standard ISO 10993-1 "Biological Evaluation of Medical
Devices - Part 1: Evaluation and Testing Within a Risk Management
Process" as recognized by FDA. |
| | The new devices Airlock® Centrolock® osteosynthesis implant system
implants have similar technological characteristics in terms of material
(ISO 5832-3 Fourth edition 2016-10-15 Implants For Surgery - Metallic
Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy)
and thus are believed to be substantially equivalent to the primary
predicate legally marketed device OrthoHelix Surgical Designs Mini
MaxLock Extreme® Plating System (K120157), and the reference device
marketed Novastep Airlock® osteosynthesis Plate System (K143523). |
| | The new devices Airlock® Centrolock® osteosynthesis implant system
screws have similar technological characteristics in terms of material (ISO
5832-3 Fourth edition 2016-10-15 Implants For Surgery - Metallic
Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy)
and thus are believed to be substantially equivalent to the primary
predicate legally marketed device OrthoHelix Surgical Designs Mini
MaxLock Extreme® Plating System (K120157), and the reference device
marketed Novastep Airlock® osteosynthesis Plate System (K143523). |
| Indication for 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. |
| 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
substantially equivalent to the primary predicate device OrthoHelix
surgical designs Mini MaxLock Extreme® Plating System (K120157), to the
reference Novastep Airlock® osteosynthesis plate systems (K143523), and
to the other predicate Wright Medical Technology MICA™ Screw System
(K162353) in terms of intended use and indications for use.
The Airlock® Centrolock® osteosynthesis implant systems are
substantially equivalent to the primary predicate device OrthoHelix
surgical designs Mini MaxLock Extreme® Plating System (K120157), to the
reference Novastep Airlock® osteosynthesis plate systems (K143523) in
terms of material, design and function. |
| | Any minor differences between these devices do not raise new questions
of safety and effectiveness. |
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