510(k) · Cleared
Recalled · Class II · 2020Smith 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jul 28, 2015 as substantially equivalent to K011299 (Smith & Nephew, Inc., 2001) and 7 other predicates after a 95-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it. It has been recalled 40 times.
- Decided
- Jul 28, 2015
- Review
- 95 days
- Class
- Class II
- Product code
- MAI
- Recalls
- 40
- Predicates
- 8
Its longest line of descent runs back 8 generations to K961555 (1996). 36 ancestors in all, the oldest K925573 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 4 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 3 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- 2 generations backK101459 Osteoraptor II Suture Anchor or to BE Determined Model: 72202764…Smith & Nephew, Inc. · 2011
- 1 generation backK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013
- This deviceK151105 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor…Smith & Nephew, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK163672 Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −4 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −3 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| −2 | K101459 | Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765… | Smith & Nephew, Inc. | 2011 | — |
| −1 | K123393 | Healicoil Suture Anchor with Regenesorb | Smith & Nephew, Inc. | 2013 | — |
| 0 (this device) | K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and… | Smith & Nephew, Inc. | 2015 | — |
| +1 | K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor | Nanova Biomaterials, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011299 | Smith and Nephew 5.00MM Absorbable Polymer AnchorSummary page 11…Device Name Clearance Number Date K011299 SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER 06/27/2001 ANCHOR K031685 TAG… | 2001 |
| * | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318Summary page 11…Date K011299 SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER 06/27/2001 ANCHOR K031685 TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 07/01/2003 K071586 Bioraptor 2.3 PK Suture Anch… | 2003 |
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 11…ABSORBABLE POLYMER 06/27/2001 ANCHOR 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… | 2007 |
| * | K082215 | Osteoraptor Suture AnchorSummary page 11…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… | 2008 |
| * | K093844 | Smith & Nephew Twinfix Ultra HA Suture AnchorSummary page 11…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 An… | 2010 |
| * | K103309 | Osteoraptor Curved 2.3 Suture AnchorsSummary page 11…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-FI… | 2011 |
| * | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Summary page 11…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 10/18/2012 SYSTEM, SMITH & NEPHEW ULTRA… | 2012 |
| * | K123393 | Healicoil Suture Anchor with RegenesorbSummary page 12…K151105 - Page 2 of 7 REPAIR SYSTEM, SMITH & NEPHEW FAST-FIX 360 MENISCAL REPAIR SYSTEM K123393 HEALICOIL SUTURE ANCHOR WITH REGENESORB 04/11/2013 Device Description Smith & Nephew Absorba… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2020 | Class II | Z-0136-2021 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 | Equipment maintenance | 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 |
The 5 latest of 40 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 14 of the 36 ancestors have a recall of any class.
- Of its descendants, K163672 (Nanova Biomaterials, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K011299.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
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…
Read the full statement (866 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151105 · printed Nov 5, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151105
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026