(83 days)
Not Found
No
The document describes a mechanical suture anchor and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the "reattachment of soft tissue to bone," which is a therapeutic purpose aimed at treating or alleviating a medical condition (soft tissue detachment).
No
The device is described as a suture anchor for the reattachment of soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that the devices are suture anchors made from PLA and titanium, incorporating suture material and stainless steel inserters. These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reattachment of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "suture anchor" made of materials like PLA and titanium, incorporating suture material. This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair tissue within the body.
N/A
Intended Use / Indications for Use
The Smith & Nephew BIORAPTOR 2.9 and TwinFix Ti 2.8 & 3.5 suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP lesion repairs Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis
Foot and Ankle Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Knee
Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis
Hip
Capsular repair Acetabular labral repair
Product codes
HWC, MBI, JDR, MAI
Device Description
BioRaptor: Preloaded 2.9 mm suture anchor manufactured from PLA (Poly(L-Lactide)) incorporating either ultra high molecular weight polyethelene suture or polyester suture on a stainless steel inserter.
TwinFix: 2.8 and 3.5mm titanium suture anchor incorporating either ultra high molecular weight polyethylene or polyester suture. TwinFix anchors are available preloaded on a stainless steel inserter shaft or unassembled. TwinFix anchors are available with or a stammess stool inserter shaft is available in two lengths, regular and XL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hip
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)
The performance testing conducted includes bench and cadaver testing that demonstrates substantial equivalence for the indication of hip labral to soft tissue repair in other joints.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K053344 Page 1 of 4
FEB 2 3 2006
SECTION IV SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
STOR SOMMERS OF OF 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Indication Expansion -- TwinFix Ti 2.8 & 3.5/BioRaptor 2.9
Date Prepared: December 1, 2005
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Deana Boushell Principle Regulatory Affairs Specialist (508) 337-4036 Phone: (508) 261-3620 FAX:
C. Device Name
| Trade Name: | TwinFix Ti 2.8 & 3.5 | BioRaptor 2.9 |
|---|---|---|
| Common Name: | Suture Anchor | Suture Anchor |
| Classification Name: | Fastener, Fixation, | |
| non-degradable, soft tissue | Fastener, Fixation, | |
| degradable, soft tissue |
D. Predicate Devices
The indication of hip labral repair is substantially equivalent to the currently Fire multications for use of the following legally marketed devices in marketed indications for ass of the Smith & Nephew TwinFix Ti 2.8 & 3.5 (K972326) BioRaptor 2.9 (K031683).
1
Kc1-3344 P62-12
E. Description of Device
BioRaptor
Preloaded 2.9 mm suture anchor manufactured from PLA (Poly(L-Lactide)) incorporating either ultra high molecular weight polyethelene suture or polyester suture on a stainless steel inserter.
TwinFix
2.8 and 3.5mm titanium suture anchor incorporating either ultra high molecular weight polyethylene or polyester suture. TwinFix anchors are available preloaded on a stainless steel inserter shaft or unassembled. TwinFix anchors are available with or a stammess stool inserter shaft is available in two lengths, regular and XL.
Intended Use F.
The intended use of the currently available suture anchors remains unchanged. The suture anchors are intended for the fixation of soft tissue to bone.
G. Comparison of Technological Characteristics
There are no changes to the existing devices. Technological Characteristics remain the same.
H. Summary Performance Data
The performance testing conducted includes bench and cadaver testing that demonstrates substantial equivalence for the indication of hip labral to soft tissue repair in other joints.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2006
Ms. Deana Boushell Principle Regulatory Affairs specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, MA 01810
K053344 Re:
Trade/Device Name: TwinFix 2.8mm, 3.5mm and BioRaptor 2.9mm Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR, MAI Dated: January 27, 2006 Received: January 30, 2006
Dear Ms. Boushell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Ms. Deana Boushell
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. product indiation of to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse organ finding of substantial equivalence of your device to a legally premailed notificated on "ce results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dealer of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oixor general manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
05354
Device Name: BioRaptor and TwinFix Ti 2.8 & 3.5 Suture Anchors
Indications For Use.
The Smith & Nephew BIORAPTOR 2.9 and TwinFix Ti 2.8 & 3.5 suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP lesion repairs Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis
Foot and Ankle Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Knee
Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis
Hip
Capsular repair Acetabular labral repair
Prescription Use ____x
(Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No
FR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number_