(252 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a bioabsorbable threaded anchor system, with no mention of AI or ML capabilities.
Yes
The device is described as a "threaded anchor system" intended for "fixation of suture (soft tissue) to bone" in various anatomical locations for the purpose of repairing injuries (e.g., Rotator Cuff Repair, ACL Repair). This direct physiological intervention for treating anatomical issues falls under the definition of a therapeutic device.
No
The device, FIXIT® threaded anchor system, is described as an implant intended for fixation of suture to bone in various anatomical regions. Its description and intended use clearly indicate it is a surgical implant designed for repair procedures, not for identifying or characterizing diseases or conditions.
No
The device description clearly states that the FIXIT® system is a threaded anchor system made of a composite, bioabsorbable material and is supplied as a physical implant (threaded anchor) with or without sutures and a screwdriver. This indicates it is a physical medical device, not software-only.
Based on the provided information, the FIXIT® threaded anchor system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of suture (soft tissue) to bone" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a physical implant (threaded anchor system) made of a bioabsorbable material, designed to be surgically placed within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health, diagnosis, or condition. This is the core function of an IVD.
- Performance Studies: The performance studies focus on biocompatibility, biological, and mechanical performance of the implant itself, not on the accuracy or reliability of a diagnostic test.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. The FIXIT® system is an in vivo (within the body) surgical implant.
N/A
Intended Use / Indications for Use
The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;
Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material.
The implant is available in 2 different configurations:
- FIXIT®Knotless: supplied in a holder,
- FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures.
The implant is supplied sterile, ready to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, foot/ankle, knee, hand/wrist, and elbow
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 performance testing including biocompatibility, biological and mechanical performances was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices.
Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits.
Clinical performance data was not included.
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
S.B.M. SAS Science for Bio Materials Ms. Anne Cospin-Latapie Quality/Regulatory Affairs Manager ZI du Monge Lourdes, France 65100
November 30, 2017
Re: K170868
Trade/Device Name: FIXIT Threaded Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: October 19, 2017 Received: October 23, 2017
Dear Ms. Cospin-Latapie:
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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K170868
Device Name FIXIT Threaded Anchor System
Indications for Use (Describe)
The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;
Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair
| 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) |
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Image /page/3/Picture/1 description: The image shows the logo for Science & Bio Materials (SBM). The letters S, B, and M are displayed in a horizontal line, with the B in blue and the other letters in gray. Below the letters is the text "Science & Bio Materials" in a smaller font. To the right of the letters are three right-pointing triangles, with the middle triangle having a blue gradient.
510(k) SUMMARY
1. SUBMITTER
| S.B.M. SAS |
|---|
| SCIENCE FOR BIOMATERIALS |
| ZI du Monge |
| F 65100 LOURDES - FRANCE |
| Registration Number: 3004549189 |
| Phone: +33 (0)5 62 42 21 01 |
| Fax: +33 (0)5 62 42 21 00 |
| Contact Person: Anne COSPIN-LATAPIE |
| e-mail : anne.cospin@sbm-fr.com |
| Date prepared: November 29, 2017 |
2. DEVICE
| Name of Device | FIXIT® Threaded Anchor System |
|---|---|
| Common or Usual Name | Suture Anchor |
| Classification Name | Fastener, fixation, biodegradable, |
| soft tissue | |
| Regulatory Class | II |
| Product Code | MAI |
3. PREDICATE DEVICE
Arthrex Bio-Composite Corkscrew manufactured by Arthrex, Inc., K082810
Referenced devices:
K070673 Force Fiber® Black Co-braid Polyethylene non-absorbable Suture
K063778 Force Fiber® Polyethylene non-absorbable Suture
4. DEVICE DESCRIPTION
FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material.
The implant is available in 2 different configurations:
- · FIXIT®Knotless: supplied in a holder,
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Image /page/4/Picture/1 description: The image is a logo with the letters SBM in different colors. The letter B is in blue, while the letters S and M are in gray. Underneath the letters is the text "Science & Bio Materials" in a smaller font. To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue gradient pattern.
- FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures.
The implant is supplied sterile, ready to use.
5. INDICATIONS FOR USE
The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;
Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction,
Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
FIXIT® Threaded Anchor System is compared to Arthrex Bio-Composite Corkscrew (K082810) manufactured by Arthrex, Inc.
The applicant device has the same intended use as the predicate device.
The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device. This device and its predicates use similar performance characteristics, manufacturing materials, and design.
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Image /page/5/Picture/1 description: The image shows the logo for Science & Bio Materials (SBM). The letters S and M are in gray, while the letter B is in blue. The words "Science & Bio Materials" are written in a smaller font size below the letters. To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue grid pattern.
| | FIXIT® Threaded
Anchor System | Arthrex Bio-Composite
Corkscrew |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | Present submission | K082810 |
| Intended use
(same) | Fixation of suture (soft tissue) to bone | |
| | Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP
Lesion Repair; Biceps Tenodesis; Acromio-clavicular
Separation Repair; Deltoid Repair; Capsule Shift or
Capsulolabral Reconstruction; | |
| | Ankle/Foot: Lateral Stabilization; Medial Stabilization;
Achilles Tendon Repair; Hallux Valgus Reconstruction;
Mid-foot Reconstruction, Metatarsal Ligament Repair/
Tendon Repair, Bumonectomy; | |
| Indications for
use (same) | Knee: Anterior Cruciate Ligament Repair; Medial
Collateral Ligament Repair; Lateral Collateral Ligament
Repair; Patellar Tendon Repair ; Posterior Oblique
Ligament Repair; Iliotibial Band Tenodesis ; | |
| | Wrist/Hand: Scapholunate Ligament Reconstruction;
Ulnar or Radial Collateral Ligament Reconstruction,
Radial Collateral Ligament Reconstruction. | |
| | Elbow: Biceps Tendon Reattachment; Ulnar or Radial
Collateral Ligament Reconstruction; Tennis Elbow Repair
and Lateral Epicondylitis Repair, | |
| Materials | TCP/PLDLA | TCP/PLLA or TCP/PLDLA |
| | Ø 4,5mm x14,5 mm, 2
sutures | Ø 4,5mm x15 mm, 2
sutures |
| Configuration/
dimensions | Ø 5,5mm x17,6 mm, 2
sutures | Ø 5,5mm x15 mm, 2 or 3
sutures |
| | Ø 6,5mm x17,6 mm, 2
sutures | Ø 6,5mm x15 mm, 2 or 3
sutures |
| Packaging | Anchor loaded with suture
on driver sealed in foil
pouch | Anchor loaded with suture
on driver sealed in plastic
tray with Tyvek pouch,
which is then sealed in a foil
pouch |
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Image /page/6/Picture/1 description: The image shows a logo with the letters S, B, and M. The letter B is in blue, while the letters S and M are in gray. Below the letters is the text "Science & Bio Materials". To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue gradient pattern.
4. PERFORMANCE DATA
Non-clinical performance testing
Non-clinical testing including biocompatibility, biological and mechanical performances was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices.
Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits.
Clinical performance testing:
Clinical performance data was not included.
5. CONCLUSIONS
The FIXIT® Threaded Anchor System is substantially equivalent to its predicate device Arthrex Bio-Composite Corkscrew (K082810). Verification and validation tests demonstrate that the FIXIT® Threaded Anchor System is as safe, as effective, and performs as safely and effectively as its predicate device.