# K151105: 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 Fa

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 28, 2015 after 95 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 40 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K961555 (1996). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011299: Smith and Nephew 5.00MM Absorbable Polymer Anchor, Smith & Nephew, Inc. (2001) Summary page 11.
- K031685: Tag Rod Bioraptor Suture Anchor 7209317, 7209318, Smith & Nephew, Inc. (2003) Summary page 11.
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 11.
- K082215: Osteoraptor Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2008) Summary page 11.
- K093844: Smith & Nephew Twinfix Ultra HA Suture Anchor, Smith & Nephew, Inc. (2010) Summary page 11.
- K103309: Osteoraptor Curved 2.3 Suture Anchors, Smith & Nephew Endoscopy, Inc. (2011) Summary page 11.
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N, Smith & Nephew, Inc. (2012) Summary page 11.
- K123393: Healicoil Suture Anchor with Regenesorb, Smith & Nephew, Inc. (2013) Summary page 12.

## Most influential descendants
- K163672: Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor (2017), 0 descendants of its own

## Recalls of this device
- Sep 9, 2020 · Class II · Z-0136-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0141-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0144-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0152-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0153-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0157-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0160-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0166-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0169-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0172-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0137-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0138-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0139-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0142-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0143-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0145-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0146-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0148-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0149-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0150-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0151-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0159-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0165-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0167-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0171-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0173-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0175-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0154-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0155-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0156-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0158-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0161-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0162-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0168-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0140-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0147-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0163-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0164-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0170-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Sep 9, 2020 · Class II · Z-0174-2021: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

## 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: 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 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 Elbow, Wrist, and Hand: 1. Scapholunate ligament reconstructions 2. Ulnar or radial collateral ligament reconstructions 3. Lateral epicondylitis repair 4. Biceps tendon reattachment 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 The Smith & Nephew TAG Bioraptor Suture Anchor 7209317, 7209318 indications are: 1. Bankart Lesion Repair 2. Rotator Cuff Repair 3. Capsular Stabilization 4. Anterior Shoulder Instability Repair 5. Repair of ligaments and tendons of the elbow, foot, and ankle including the treatment of: - Bunionectomy - Lateral ankle instability - Biceps tendon reattachment 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 Iliotibial band tenodesis 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 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 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 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. 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

Source page: https://510kreport.com/device/K151105
Methodology: https://510kreport.com/methodology