510(k) · Cleared
Recalled · Class II · 2024PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 2, 2015 as substantially equivalent to K972326 (Orthopaedic Biosystems, Ltd., 1998) and 8 other predicates after an 84-day review. Its family tree reaches back 9 generations to 1996. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 2, 2015
- Review
- 84 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 2
- Predicates
- 9
Its longest line of descent runs back 9 generations to K961555 (1996). 42 ancestors in all, the oldest K941364 (1994). 6 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations between
- 3 generations backK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
- 2 generations backK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
- 1 generation backK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
- This deviceK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK251627 BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid…Smith & Nephew, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242477 Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243665 Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK…ZheJiang Decans Medical Devices Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK232725 Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK232005 HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL…Smith & Nephew, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 8 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 7 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 6 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 5 generations backK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
- 4 generations backK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
- 3 generations backK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
- 2 generations backK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
- 1 generation backK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
- This deviceK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc. · 2025 · cites it directly0descendants
- K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025 · cites it directly0descendants
- K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd. · 2025 · cites it directly0descendants
- K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd. · 2023 · cites it directly0descendants
- K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −8 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −7 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −6 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −5 | K070908 | Smith & Nephew Kinsa RC Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| −4 | K072785 | Twinfix FT PK | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| −3 | K093228 | Smith & Nephew Twinfix Ultra PK Suture Anchor | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100159 | Smith and Nephew Twinfix Ultra TI Suture Anchor | Smith & Nephew Inc., Endoscopy Div. | 2010 | 4 |
| −1 | K112526 | Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01… | Smith & Nephew, Inc. | 2015 | — |
| +1 | K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue)… | Smith & Nephew, Inc. | 2025 | — |
| +1 | K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. | 2025 | — |
| +1 | K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor… | ZheJiang Decans Medical Devices Co., Ltd. | 2025 | — |
| +1 | K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | Suzhou Endophix Co., Ltd. | 2023 | — |
| +1 | K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture… | Smith & Nephew, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (9)
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 |
|---|---|---|---|
| * | K972326 | Peba Anchor/Suture CombinationSummary page 21…Device Name Clearance Number Date K972326 PEBA ANCHOR/SUTURE COMBINATION 02/06/1998 K000797 2.0mm MINI-TAC ANCHOR,… | 1998 |
| * | K000797 | Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01Summary page 21…Date K972326 PEBA ANCHOR/SUTURE COMBINATION 02/06/1998 K000797 2.0mm MINI-TAC ANCHOR, MODEL 10-1629-01 04/03/2000 K023021 MODIFICATION TO SMITH… | 2000 |
| * | K023021 | Modification to Smith & Nephew Twinfix TI Quick TSummary page 21…NCHOR/SUTURE COMBINATION 02/06/1998 K000797 2.0mm MINI-TAC ANCHOR, MODEL 10-1629-01 04/03/2000 K023021 MODIFICATION TO SMITH & NEPHEW TWINFIX TI 10/04/2002 QUICK-T K072785… | 2002 |
| * | K072785 | Twinfix FT PKSummary page 21…629-01 04/03/2000 K023021 MODIFICATION TO SMITH & NEPHEW TWINFIX TI 10/04/2002 QUICK-T K072785 Twinfix FT PK 12/10/2007 K102660 BIORAPTOR CURVED 2.3 P… | 2007 |
| * | K102660 | Bioraptor Curved 2.3 PK Suture AnchorsSummary page 21…INFIX TI 10/04/2002 QUICK-T K072785 Twinfix FT PK 12/10/2007 K102660 BIORAPTOR CURVED 2.3 PK Suture Anchors 12/13/2010 K112526 TWINFIX ULTRA TI, TWIN… | 2010 |
| * | K112526 | Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSummary page 21…x FT PK 12/10/2007 K102660 BIORAPTOR CURVED 2.3 PK Suture Anchors 12/13/2010 K112526 TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX 01/31/2012 ULTRA HA Suture Anchor… | 2012 |
| * | K113274 | Footprint Ultra PK Suture AnchorSummary page 21…12/13/2010 K112526 TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX 01/31/2012 ULTRA HA Suture Anchors K113274 FOOTPRINT Ultra PK suture anchors 03/06/2012 K113294 SMITH & NEPHEW Healico… | 2012 |
| * | K113294 | Smith & Nephew Healicoil PK Suture AnchorSummary page 21…01/31/2012 ULTRA HA Suture Anchors K113274 FOOTPRINT Ultra PK suture anchors 03/06/2012 K113294 SMITH & NEPHEW Healicoil PK Suture Anchor 01/20/2012 K121018 Smith & Nephew, Inc. B… | 2012 |
| * | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSummary page 21…INT Ultra PK suture anchors 03/06/2012 K113294 SMITH & NEPHEW Healicoil PK Suture Anchor 01/20/2012 K121018 Smith & Nephew, Inc. BIORAPTOR 2.9 Suture Anchor, 06/22/2012 BIORAPTOR 2.3 PK Sutur… | 2012 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3… | 2025 | 0 |
| K242477 | Shoulder Soft Tissue Anchors | 2025 | 0 |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System… | 2025 | 0 |
| K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | 2023 | 0 |
| K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor… | 2023 | 0 |
| K213104 | Auxilock Titanium Screw-In Suture Anchor | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2024 | Class II | Z-0581-2025 | Package design/selection | Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. |
| Dec 30, 2019 | Class II | Z-1273-2020 | Package design/selection | Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 9 of the 42 ancestors have a recall of any class.
- Of its descendants, K251627 (Smith & Nephew, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K972326.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, 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 · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures. The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. The PeBA Series Anchor/Suture Combination is…
Read the full statement (1,172 words)
This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.
The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:
Shoulder:
1. Bankart lesion repairs
2. SLAP lesion repairs
3. Acromio-clavicular separation repairs
4. Rotator cuff tear repairs
5. Capsular shift or capsulolabral reconstructions
6. Biceps tenodesis
7. Deltoid repairs
Foot and Ankle:
. Hallux Valgus repairs
. Medial or lateral instability repairs
. Achilles tendon repairs/reconstructions
. Midfoot reconstructions
. Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand:
. Scapholunate ligament reconstructions
. Ulnar or radial collateral ligament reconstructions
. Tennis elbow repair
. Biceps tendon reattachment
Knee:
1. Extra-capsular repairs
a. medial collateral ligament
b. lateral collateral ligament
¢. posterior oblique ligament
2. lliotibial band tenodesis
3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
The OBL Preloaded Series Anchor is intended for use only for the fixation of non-absorbable synthetic suture material for the following indications:
Shoulder:
1. Bankart lesion repairs
2. SLAP lesion repairs
3. Acromio-clavicular 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
*Pelvis:
2. Bladder neck suspension procedures
* This indication is marketed separately from the orthopedic indications under the trade name Cinch®
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist, and hand. Examples of such procedures include:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs.
Foot and Ankle:
Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.
Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, unler or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.
Knee:
Extra-capsular repairs: medial collateral ligament, lateral collateral ligament, and posterior oblique ligament. [liotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankhart Repair
SLAP lesion repairs
Capsular shift or capsulolabral Reconstructions
Acomioclavicular 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
Elbow:
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Biceps tendon reattachment
Knee:
Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
Patellar realignment and tendon repairs:
- Vastus medialis obliquous advancement
Iliotibial band tenodesis
The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs
SLAP lesion repairs
Acromioclavicular separation repairs
Rotator cuff tear repairs
Capsular shift or capsulolabral reconstructions
Biceps tenodesis
Deltoid repairs
Foot and Ankle:
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Elbow:
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Biceps tendon reattachment
Knee:
Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
Iliotibial band tenodesis
Patellar realignment and tendon repairs:
- Vastus medialis obliquous advancement
Hip:
Abductor tendon repair
The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip:
Hip capsular repair
-Acetabular labral repair
Shoulder:
Capsular Stabilization
- Bankart Repair
-Anterior Shoulder Instability Repair
-SLAP lesion repairs
-Capsular Shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator Cuff tear repairs
Biceps tenodesis
Foot and Ankle:
Hallux valgus repairs
Medial or lateral 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
lliotibial band tenodesis
The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair
» Acetabular labrum reattachment/reconstruction
Shoulder
Capsular stabilization
* Bankart repair
« Anterior shoulder instability
* SLAP lesion repairs
« Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator Cuff 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 Next Generation Fully Threaded PEEK Suture Anchor is intended for use 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
Hip:
Gluteal tendon repairs
- Gluteus medius and gluteus minimus repair
The Smith & Nephew BIORAPTOR Curved 2.3 PK 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
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152566: PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152566
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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