(67 days)
Not Found
No
The device description and intended use are purely mechanical, describing a suture anchor and its application in soft tissue reattachment. There is no mention of any computational or analytical capabilities, let alone AI/ML.
Yes
The device is described as a "Suture Anchor" intended for the "reattachment of soft tissue to bone" for various repairs and reconstructions across multiple anatomical sites. This indicates it is used for treatment, which falls under the definition of a therapeutic device.
No
The document describes a suture anchor used for reattaching soft tissue to bone, which is a therapeutic or reparative function, not a diagnostic one.
No
The device description clearly states it is a physical suture anchor made from PEEK polymer with attached suture and a stainless steel inserter. This is a hardware 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 description and intended use of the Smith & Nephew BIORAPTOR Suture Anchor clearly indicate it is a surgical implant used to reattach soft tissue to bone within the body. It is a physical device used in surgical procedures, not a test performed on a sample.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
These suture anchors are intended for the fixation of soft tissue to bone in the Hip, Shoulder, Foot, Ankle, Elbow, Wrist, Hand and Knee as follows:
Hip
Hip capsule repair
- Acetabular labrum reattachment
Shoulder
Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair
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
Foot and Ankle
Rotator cuff tear repairs Biceps tenodesis
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Elbow, Wrist, and Hand
reconstructions
Knee
Biceps tendon reattachment
Lateral epicondylitis repair
Extra-capsular repairs: - Medial collateral ligament
-
Lateral collateral ligament
-
Posterior oblique ligament
Iliotibial band tenodesis
Patellar realignment and tendon repairs
- Vastus medialis obliquous advancement
Ulnar or radial collateral ligament
Hip Hip capsule repair - Acetabular labrum reattachment
Shoulder
- Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs
Foot and Ankle
Biceps tenodesis
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Product codes
MBI
Device Description
Non-bioabsorbable 2.3 mm suture anchor manufactured from PEEK Optima® polymer with attached non-bioabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a stainless steel inserter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Shoulder, Foot, Ankle, Elbow, Wrist, Hand, Knee
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 demonstrates that the insertion and fixation properties of the BIORAPTOR PK anchor are substantially equivalent to the Smith & Nephew BIORAPTOR OC and the Smith & Nephew KINSA anchors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
BIORAPTOR PK Suture Anchor
Date Prepared: 06 AUG 2007
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover, MA 01810
B. Company Contact
Julie Acker, RAC Regulatory Affairs Specialist Phone: (508) 261-3618 FAX: (508) 261-3620
C. Device Name
| Trade Name: | BIORAPTOR 2.3 PK Suture Anchor |
|---|---|
| Common Name: | Fastener, fixation, non-degradable, soft tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Product Code: | MBI |
| Regulation Number: | 21 CFR §888.3040 |
D. Predicate Devices
The Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: BIORAPTOR 2.3 OC Suture Anchor (K063726) and KINSA Suture Anchor (K061154).
Description of Device E.
Non-bioabsorbable 2.3 mm suture anchor manufactured from PEEK Optima® polymer with attached non-bioabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a stainless steel inserter.
1
F. Intended Use
These suture anchors are intended for the fixation of soft tissue to bone in the Hip, Shoulder, Foot, Ankle, Elbow, Wrist, Hand and Knee as follows:
Hip
Hip capsule repair
- Acetabular labrum reattachment
Shoulder
Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair
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
Foot and Ankle
Rotator cuff tear repairs Biceps tenodesis
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
G. Comparison of Technological Characteristics
The Smith & Nephew BIORAPTOR PK Suture Anchor is substantially equivalent to the Smith & Nephew BIORAPTOR OC Suture Anchor (K063726). The BIORAPTOR PK anchor design is identical to that of the predicate anchor (K063726). The only difference is the anchor material which is a non-biodegradable polymer. This material is identical to that used in the Smith & Nephew KINSA Suture Anchor (K061154).
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the BIORAPTOR PK anchor are substantially equivalent to the Smith & Nephew BIORAPTOR OC and the Smith & Nephew KINSA anchors.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Ms. Julie Acker, RAC 150 Minuteman Rd. Andover, MA 01810
AUG 1 7 2007
Re: K071586
Trade/Device Name: BIORAPTOR 2.3 PK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: August 6, 2007 Received: August 7, 2007
Dear Ms. Acker:
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 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.
3
Page 2 -- Ms. Julie Acker
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchm
Mark N. Me 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):
Device Name: BIORAPTOR 2.3 PK Suture Anchor
The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Elbow, Wrist, and Hand
reconstructions
Knee
Biceps tendon reattachment
Lateral epicondylitis repair
Extra-capsular repairs: - Medial collateral ligament
-
Lateral collateral ligament
-
Posterior oblique ligament
Iliotibial band tenodesis
Patellar realignment and tendon repairs
- Vastus medialis obliquous advancement
Ulnar or radial collateral ligament
Hip Hip capsule repair - Acetabular labrum reattachment
Shoulder
- Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs
Foot and Ankle
Biceps tenodesis
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Per 21 CFR 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)
Sabara Boehn
Division of General. Restorative. and Neurological Devices
510(k) Number K071586
હી હ