(95 days)
Not Found
No
The device description and intended use clearly describe a physical implant (suture anchor) and its mechanical function for tissue reattachment. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an absorbable polymer anchor and suture anchors intended for the reattachment and fixation of soft tissue to bone, which is a therapeutic function aimed at treating injuries or conditions.
No
The device is a surgical anchor used for reattaching soft tissue to bone, which is a treatment or repair function, not a diagnostic one.
No
The device description clearly states that the device is a physical implant (absorbable suture anchor) provided with hardware components like an inserter, sutures, and needles. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used 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 described as a "Suture Anchor" made of absorbable materials, pre-assembled onto an inserter, and used with sutures and needles. This aligns with a surgical implant or device used during a procedure.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with patient specimens.
The device is a surgical implant used to physically repair damaged tissue within the body, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Smith & Nephew Suture Anchors – 5.0mm Absorbable Polymer Anchor: The Smith & Nephew 5.0 Absorbable Polymer Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
- Shoulder: 1. Bankart lesion repairs, 2. SLAP lesion repairs, 3. Acromioclavicular separation repairs, 4. Rotator cuff tear repairs, 5. Capsular shift or capsulolabral reconstructions, 6. Biceps tenodesis, 7. Deltoid repairs
- Elbow, Wrist, and Hand: 1. Scapholunate ligament reconstructions, 2. Ulnar or radial collateral ligament reconstructions, 3. Lateral epicondylitis repair, 4. Biceps tendon reattachment
- Foot and Ankle: 1. Hallux valgus repairs, 2. Medial or lateral instability repairs/reconstructions, 3. Achilles tendon repairs/reconstructions, 4. Midfoot reconstructions, 5. Metatarsal ligament/tendon repairs/reconstructions
- Knee: 1. Extra-capsular repairs: a. Medial collateral ligament, b. Lateral collateral ligament, c. Posterior oblique ligament; 2. Iliotibial band tenodesis, 3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
- Smith & Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318:
-
- Bankart Lesion Repair
-
- Rotator Cuff Repair
-
- Capsular Stabilization
-
- Anterior Shoulder Instability Repair
-
- Repair of ligaments and tendons of the elbow, foot, and ankle including the treatment of: Bunionectomy, Lateral ankle instability, Biceps tendon reattachment
-
- Smith & Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor: 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, Rotator cuff tear repairs, Biceps tenodesis
- 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: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy
- Smith & Nephew Suture Anchors – Osteoraptor Suture Anchor: The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
- Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
- Foot and Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy
- Hip: Hip capsule repair, Acetabular labrum 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
- 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, Biceps tenodesis
- Smith & Nephew Suture Anchors – Twinfix Ultra HA Suture Anchor: The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
- Shoulder: Bankart repairs, 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 instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions
- 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
- Elbow: Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment
- Smith & Nephew Suture Anchors – OSTEORAPTOR Curved Suture Anchors: The Smith & Nephew OSTEORAPTOR Curved Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
- 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, Biceps tenodesis
- Smith & Nephew Suture Anchors – Ultra Fast-Fix Meniscal Repair System, Ultra Fast-Fix AB Meniscal Repair System, Fast-Fix 360 Meniscal Repair System:
- The ULTRA FAST-FIX Meniscal Repair System is intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
- The ULTRA FAST-FIX AB Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX AB System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX AB System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
- The FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The FAST-FIX 360 System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
- Smith & Nephew Suture Anchors – Healicoil Absorbable Suture Anchor: The Smith & Nephew HEALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
- Shoulder: Bankart lesion repairs, 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 instability repairs/reconstructions, Achilles tendon repairs/reconstruction, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions
- 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
- Elbow: Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment
Product codes
MAI, HWC, JDR, MBI, GAT
Device Description
Smith & Nephew Absorbable Suture Anchors are provided in various composite absorbable materials. All of the Smith & Nephew Absorbable Suture Anchors are provided sterile, for single use only. All Smith & Nephew Absorbable Suture Anchors are pre-assembled onto an inserter, sized appropriately to accommodate the indicated procedures. Smith & Nephew Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s), and with attached stainless steel needle(s). In certain configurations, the Absorbable Suture Anchors are packaged with a guide and threaded dilator. All configurations of the Absorbable Suture Anchors are identical to the identified predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Wrist, Hand, Foot, Ankle, 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
Ship Testing and Post-Shipment mechanical functionaltesting for insertion and pullout (fixation) force demonstrates that the Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K011299, K031685, K071586, K082215, K093844, K103309, K121861, K123393
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a human face in profile, with three overlapping faces suggesting a sense of community and connection. The logo is black and white.
July 28, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Incorporated Ms. Katherine Marcaccio Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
Re: K151105
Trade/Device Name: Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor; Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317; 7209318, Smith and Nephew Suture Anchors -Bioraptor 2.3 PK Suture Anchor; Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor; Smith and Nephew Suture Anchors -Twinfix Ultra HA Suture Anchor; Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors; Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System; Ultra Fast-Fix AB Meniscal Repair System; Fast-Fix 360 Meniscal Repair System; Smith and Nephew Suture Anchors - Healicoil Absorbable Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC, JDR, MBI, GAT
Dear Ms. Marcaccio:
Dated: April 22, 2015 Received: April 24, 2015
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.
1
Page 2 - Ms. Katherine Marcaccio
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 (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 (OS) 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/ResourcesforYou/Industry/default.htm. 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.
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
2
510(k) Number (if known): ________________
Smith & Nephew Suture Anchors – 5.0mm Absorbable Polymer Anchor Device Name:
Indications for Use:
The Smith & Nephew 5.0 Absorbable Polymer Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
| Shoulder: | Elbow, Wrist, and Hand: |
|---|---|
| 1. Bankart lesion repairs | 1. Scapholunate ligament reconstructions |
| 2. SLAP lesion repairs | 2. Ulnar or radial collateral ligament reconstructions |
| 3. Acromioclavicular separation repairs | 3. Lateral epicondylitis repair |
| 4. Rotator cuff tear repairs | 4. Biceps tendon reattachment |
| 5. Capsular shift or capsulolabral reconstructions | |
| 6. Biceps tenodesis | |
| 7. Deltoid repairs | |
| Foot and Ankle: | Knee: |
| 1. Hallux valgus repairs | 1. Extra-capsular repairs: |
| 2. Medial or lateral instability repairs/reconstructions | a. Medial collateral ligament |
| 3. Achilles tendon repairs/reconstructions | b. Lateral collateral ligament |
| 4. Midfoot reconstructions | c. Posterior oblique ligament |
| 5. Metatarsal ligament/tendon repairs/reconstructions | 2. Iliotibial band tenodesis |
| 3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement |
Prescription Use X_ AND/OR (Part 21 CFR 801 subpart D)
Over-the-Counter Use _ (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
3
510(k) Number (if known): ___________
Device Name: Smith & Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318
Indications for Use:
-
- Bankart Lesion Repair
-
- Rotator Cuff Repair
-
- Capsular Stabilization
-
- Anterior Shoulder Instability Repair
-
- Repair of ligaments and tendons of the elbow, foot, and ankle including the treatment of:
- Bunionectomy
- Lateral ankle instability ।
- Biceps tendon reattachment -
Prescription Use X AND/OR (Part 21 CFR 801 subpart D)
Over-the-Counter Use _ (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
4
Smith & Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor Device Name:
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 Rotator cuff tear repairs Biceps tenodesis
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:
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 (Part 21 CFR 801 subpart D)
Over-the-Counter Use (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
5
Smith & Nephew Suture Anchors – Osteoraptor Suture Anchor Device Name:
Indications for Use:
The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair
Foot and Ankle
Hallux valgus repairs Medial or lateral instability repairs/ reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Hip
Hip capsule repair
- Acetabular labrum 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
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 Biceps tenodesis
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 subpart D)
Over-the-Counter Use _ (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
6
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Smith & Nephew Suture Anchors – Twinfix Ultra HA Suture Anchor Device Name:
Indications for Use:
The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
- Bankart repairs 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 instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
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
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 subpart D)
Over-the-Counter Use (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
7
510(k) Number (if known): ________________
Device Name: Smith & Nephew Suture Anchors – OSTEORAPTOR Curved Suture Anchors
Indications for Use:
The Smith & Nephew OSTEORAPTOR Curved Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
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
Biceps tenodesis
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 subpart D)
Over-the-Counter Use _ (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
8
Device Name: Smith & Nephew Suture Anchors – Ultra Fast-Fix Meniscal Repair System, Ultra Fast-Fix AB Meniscal Repair System, Fast-Fix 360 Meniscal Repair System
Indications for Use:
The ULTRA FAST-FIX Meniscal Repair System is intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
The ULTRA FAST-FIX AB Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX AB System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX AB System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
The FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The FAST-FIX 360 System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
Prescription Use X AND/OR (Part 21 CFR 801 subpart D)
Over-the-Counter Use (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
9
Smith & Nephew Suture Anchors – Healicoil Absorbable Suture Anchor Device Name:
Indications for Use:
Bankart lesion repairs
Rotator cuff tear repairs
Slap lesion repairs
The Smith & Nephew HEALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Shoulder:
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:
Biceps tenodesis
Deltoid repairs
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Prescription Use AND/OR (Part 21 CFR 801 subpart D)
Over-the-Counter Use (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
10
510(k) Summary
Date Prepared: May 15, 2015
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | Katherine Marcaccio |
| 150 Minuteman Road | Regulatory Affairs Specialist II |
| Andover, MA 01810 | Phone: (508) 261-3602 |
| Fax: (978) 749-1443 |
| Device Name (Unmodified) | |
|---|---|
| Trade or proprietary name | Smith & Nephew Absorbable Suture Anchors |
| Common or usual name | HWC - Screw, Fixation, Bone |
| JDR - Staple, Fixation, Bone | |
| MAI - Fastener, Fixation, Biodegradable, Soft Tissue | |
| MBI - Fastener, Fixation, Nondegradable, Soft Tissue | |
| GAT - Suture, Nonabsorbable, Synthetic, Polyethylene | |
| Classification name | 21 CFR §888.3030 – Single/multiple component metallic bone |
| fixation appliances and accessories | |
| 21 CFR §888.3040 – Smooth or threaded metallic bone | |
| fixation fastener | |
| 21 CFR §878.5000 - Nonabsorbable poly(ethylene | |
| terephthalate) surgical suture |
Legally Marketed Predicate Device
The Smith & Nephew Absorbable Suture Anchors are substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
| 510(k)
Number | Device Name | Clearance
Date |
|------------------|----------------------------------------------------------------------------------------------------|-------------------|
| K011299 | SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER
ANCHOR | 06/27/2001 |
| K031685 | TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 | 07/01/2003 |
| K071586 | Bioraptor 2.3 PK Suture Anchor | 08/17/2007 |
| K082215 | Osteoraptor Suture Anchor | 11/03/2008 |
| K093844 | SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR | 04/01/2010 |
| K103309 | OSTEORAPTOR Curved Suture Anchors | 02/03/2011 |
| K121861 | SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR
SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL | 10/18/2012 |
11
| | REPAIR SYSTEM, SMITH & NEPHEW FAST-FIX 360 MENISCAL
REPAIR SYSTEM | |
|---------|----------------------------------------------------------------------|------------|
| K123393 | HEALICOIL SUTURE ANCHOR WITH REGENESORB | 04/11/2013 |
Device Description
Smith & Nephew Absorbable Suture Anchors are provided in various composite absorbable materials. All of the Smith & Nephew Absorbable Suture Anchors are provided sterile, for single use only. All Smith & Nephew Absorbable Suture Anchors are pre-assembled onto an inserter, sized appropriately to accommodate the indicated procedures. Smith & Nephew Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s), and with attached stainless steel needle(s). In certain configurations, the Absorbable Suture Anchors are packaged with a guide and threaded dilator. All configurations of the Absorbable Suture Anchors are identical to the identified predicate devices.
Intended Use
Smith & Nephew Suture Anchors – 5.0mm Absorbable Polymer Anchor
The Smith & Nephew 5.0 Absorbable Polymer Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
Shoulder:
-
- Bankart lesion repairs
- SLAP lesion repairs 2.
- Acromioclavicular separation repairs ဒေ
- Rotator cuff tear repairs 4.
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
Foot and Ankle:
-
- Hallux valgus repairs
- Medial or lateral instability 2. repairs/reconstructions
-
- Achilles tendon repairs/reconstructions
-
- Midfoot reconstructions
-
- Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
- ဒေ Lateral epicondylitis repair
-
- Biceps tendon reattachment
- Knee:
-
- Extra-capsular repairs:
- a. Medial collateral ligament
- b. Lateral collateral ligament
- Posterior oblique ligament ﻥ
-
- Illiotibial band tenodesis
-
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
-
12
Smith & Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318
- Bankart Lesion Repair 1.
-
- Rotator Cuff Repair
- Capsular Stabilization 3.
- Anterior Shoulder Instability Repair 4.
-
- Repair of ligaments and tendons of the elbow, foot, and ankle including the treatment of:
- Bunionectomy -
- Lateral ankle instability -
- Biceps tendon reattachment -
Smith & Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor
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 Rotator cuff tear repairs Biceps tenodesis
Foot and Ankle:
- Hallux valgus repairs Medial or lateral instability repairs/ reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
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
- -Vastus medialis obliquous
- Iliotibial band tenodesis
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Smith & Nephew Suture Anchors - Osteoraptor Suture Anchor
The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair
Foot and Ankle
Hallux valgus repairs Medial or lateral instability repairs/ reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Hip
Hip capsule repair
Acetabular labrum 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
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 Biceps tenodesis
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Smith & Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor
The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart repairs 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 instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
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
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Smith & Nephew Suture Anchors – OSTEORAPTOR Curved Suture Anchors The Smith & Nephew OSTEORAPTOR Curved Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
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 Biceps tenodesis
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Smith & Nephew Suture Anchors – Ultra Fast-Fix Meniscal Repair System, Ultra Fast-Fix AB Meniscal Repair System, Fast-Fix 360 Meniscal Repair System
The ULTRA FAST-FIX Meniscal Repair System is intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
The ULTRA FAST-FIX AB Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX AB System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX AB System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
The FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The FAST-FIX 360 System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
Smith & Nephew Suture Anchors - Healicoil Absorbable Suture Anchor The Smith & Nephew HEALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs 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 instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
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
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
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Technological Characteristics
Smith & Nephew Absorbable Suture Anchors are substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices in this submission and raises no new issues of safety and efficacy.
Summary of Performance Data
Ship Testing and Post-Shipment mechanical functionaltesting for insertion and pullout (fixation) force demonstrates that the Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices.
Substantial Equivalence Information
The substantial equivalence of the Absorbable Suture Anchors is based on identical indications for use, design features, operational principles, material composition, and performance to the predicate devices listed above. Based on the identical features to the predicates, the Absorbable Suture Anchors are substantially equivalent to the predicates.