(95 days)
Not Found
No
The summary describes a physical implant (an interference screw) and its mechanical properties and degradation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an interference screw used for reattachment and repair of ligaments, tendons, and soft tissues, which are therapeutic interventions.
No
Explanation: The device is an interference screw used for reattachment and repair of ligaments, tendons, and soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an "absorbable biocomposite interference screw," which is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (an interference screw) used for fixing ligaments, tendons, and soft tissues within the body during surgical procedures. It is used for mechanical support and fixation, not for analyzing biological samples.
The information provided aligns with a surgical device used for internal fixation, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The BIOSURE REGENESORB Interference Screw is indicated for the reattachment, tendon, soft tissue, or bone-tendon-bone for the following indications:
Knee
ACL repairs PCL repairs Extra-capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Vastus medialis obliquus advancement Iliotibial band tenodesis
Shoulder
Acromioclavicular separation repairs Biceps tenodesis
Foot and Ankle
Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Metatarsal ligament/tendon repairs/reconstructions Flexor hullucis longus (FHL) Tendon transfers
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Scapholunate ligament reconstruction Tendon transfers Carpometacarpal joint arthroplasty
NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bone-tendon-bone procedures.
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The Smith & Nephew's BIOSURE REGENESORB interference screw is an absorbable biocomposite interference screw with open lateral surface area for use in fixation of ligament, tendon, soft tissue, or bone-tendon-bone repairs in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The interference screw is provided sterile, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, shoulder, foot/ankle, elbow, and hand/wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Mechanical testing data for insertion and pull out (fixation) testing demonstrates the BIOSURE REGENESORB interference screw is substantially equivalent to the currently marketed predicate devices. The in vitro degradation of the device is substantially equivalent to the predicate BIOSURE HA (K080358).
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2015
Smith & Nephew Incorporated Mr. Vivek Mukhatyar Regulatory Affairs Specialist II 150 Minuteman Drive Andover, Massachusetts 01810
Re: K142948
Trade/Device Name: BIOSURE REGENESORB Interference Screw 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: December 17, 2014 Received: December 18, 2014
Dear Mr. Mukhatyar:
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
1
(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 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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Indications for Use
510(k) Number (if known) K142948
Device Name The BIOSURE REGENESORB Interference Screw
Indications for Use (Describe)
The BIOSURE REGENESORB Interference Screw is indicated for the reattachment, tendon, soft tissue, or bone-tendon-bone for the following indications:
Knee
ACL repairs PCL repairs Extra-capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Vastus medialis obliquus advancement Iliotibial band tenodesis
Shoulder Acromioclavicular separation repairs Biceps tenodesis
Foot and Ankle Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Metatarsal ligament/tendon repairs/reconstructions Flexor hullucis longus (FHL) Tendon transfers
Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Scapholunate ligament reconstruction Tendon transfers Carpometacarpal joint arthroplasty
NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bone-tendon-bone procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
Date Prepared: December 16th, 2014
| SUBMITTER INFORMATION | CONTACT INFORMATION |
|---|---|
| Smith & Nephew, Inc. | Vivek Mukhatyar |
| 150 Minuteman Road | Regulatory Affairs Specialist II |
| Andover, MA 01810 | Phone: (978)749-1043 |
| Fax: (978)749-1443 |
| DEVICE NAME (UNMODIFIED) | |
|---|---|
| Trade or proprietary name | BIOSURE REGENESORB interference screw |
| Common or usual name | Soft Tissue Fixation Device |
| Classification name | 21 CFR §888.3030 |
| Device Class | Class II |
| Product Code | MAI |
LEGALLY MARKETED PREDICATE DEVICE
The Smith & Nephew BIOSURE REGENESORB interference screw is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
| Predicate Device | 510(k)
Number | Clearance Date |
|-----------------------------------------------------------------|------------------|----------------|
| BIOSURE HEALICOIL PK
Interference Screw | K140879 | 07/21/2014 |
| PLLA/HA Screw (BIOSURE HA) | K080358 | 12/14/2004 |
| HEALICOIL Absorbable Suture
Anchor (HEALICOIL
REGENESORB) | K123393 | 4/11/2013 |
DEVICE DESCRIPTION
The Smith & Nephew's BIOSURE REGENESORB interference screw is an absorbable biocomposite interference screw with open lateral surface area for use in fixation of ligament, tendon, soft tissue, or bone-tendon-bone repairs in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The interference screw is provided sterile, for single use only.
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INTENDED USE
The BIOSURE REGENESORB Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications:
Knee
ACL repairs PCL repairs Extra-capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Vastus medialis obliquus advancement Iliotibial band tenodesis
Shoulder
Acromioclavicular separation repairs Biceps tenodesis
Foot and Ankle
Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Metatarsal ligament/tendon repairs/reconstructions Flexor hullucis longus (FHL) Tendon transfers
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Scapholunate ligament reconstruction Tendon transfers Carpometacarpal joint arthroplasty
NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bonetendon-bone procedures.
TECHNOLOGICAL CHARACTERISTICS
Smith & Nephew BIOSURE REGENESORB interference screw is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices - Smith and Nephew BIOSURE HEALICOIL PK interference screw (K140879), HEALICOIL Absorbable Suture Anchor and BIOSURE HA (K080358) and raises no new issues of safety and efficacy. Smith & Nephew BIOSURE REGENESORB interference screw and the predicate Smith & Nephew HEALICOIL Absorbable Suture Anchor (K123393) are manufactured from the same composite material. Smith & Nephew BIOSURE HEALICOIL interference screw and the predicate BIOSURE HA (K080358) share the same thread structure and are both absorbable interference screws. BIOSURE REGENESORB has a similar open lattice design to the BIOSURE HEALICOIL PK interference screw (K140879).
SUMMARY OF PERFORMANCE DATA
Mechanical testing data for insertion and pull out (fixation) testing demonstrates the BIOSURE REGENESORB interference screw is substantially equivalent to the currently marketed predicate devices. The in vitro degradation of the device is substantially equivalent to the predicate BIOSURE HA (K080358).
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Substantial Equivalence Information
The substantial equivalence of the BIOSURE REGENESORB interference screw is based on similarities in indications for use, design features, operational principles, material composition, and performance to the predicate devices listed above. Based on the similarities to the predicates, the BIOSURE REGENESORB interference screw is substantially equivalent to its predicates.