510(k) · Cleared
Recalled · Class II · 2013Osteoraptor Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Inc., Endoscopy Division · JDR Staple, Fixation, Bone
Cleared on Nov 3, 2008 as substantially equivalent to K053344 (Smith & Nephew, Inc., 2006) and 1 other predicate after an 89-day review. Its family tree reaches back 5 generations to 1996. 46 later devices descend from it. It has been recalled 9 times.
- Decided
- Nov 3, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- JDR
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 5 generations to K961555 (1996). 7 ancestors in all. 46 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 2 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 1 generation backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- This deviceK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008
- Descendant · cites it directly · 29 of its ownK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
- Descendant · cites it directly · 16 of its ownK093844 Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 13 of its ownK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 10 of its ownK101459 Osteoraptor II Suture Anchor or to BE Determined Model: 72202764…Smith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc. · 2012 · cites it directly29descendants
- K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010 · cites it directly16descendants
- K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012 · 2 generations on13descendants
- K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766…Smith & Nephew, Inc. · 2011 · cites it directly10descendants
- K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −4 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −3 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −2 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −1 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| 0 (this device) | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| +1 | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an | Smith & Nephew, Inc. | 2012 | — |
| +1 | K093844 | Smith & Nephew Twinfix Ultra HA Suture Anchor | Smith & Nephew, Inc. | 2010 | 11 |
| +2 | K112526 | Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors | Smith & Nephew, Inc. | 2012 | — |
| +1 | K101459 | Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765… | Smith & Nephew, Inc. | 2011 | — |
| +2 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01… | Smith & Nephew, Inc. | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 2 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…ally equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: BIORAPTOR 2.9 Anchor (K053344) and BIORAPTOR 2.3 PK Anchor (K071586}. E. Description of Device The device consists of a suture anchor with attached no… | 2006 |
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 1…Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: BIORAPTOR 2.9 Anchor (K053344) and BIORAPTOR 2.3 PK Anchor (K071586}. E. Description of Device The device consists of a suture anchor with attached non-absorbable suture(s) preassembled to… | 2007 |
What descends from it? (46)
See all 468 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an | 2012 | 29 |
| K093844 | Smith & Nephew Twinfix Ultra HA Suture Anchor | 2010 | 16 |
| K101459 | Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766… | 2011 | 10 |
| K180361 | MICRORAPTOR REGENESORB Suture Anchor | 2018 | 4 |
| K103309 | Osteoraptor Curved 2.3 Suture Anchors | 2011 | 2 |
| K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | 2016 | 1 |
| K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew… | 2015 | 1 |
| K193245 | Dunamis PunchTac Suture Anchors | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2013 | Class II | Z-2226-2013 | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
| Aug 6, 2013 | Class II | Z-2222-2013 | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
| Aug 6, 2013 | Class II | Z-2223-2013 | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
| Aug 6, 2013 | Class II | Z-2224-2013 | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
| Aug 6, 2013 | Class II | Z-2220-2013 | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
| Aug 6, 2013 | Class II | Z-2221-2013 | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
| Aug 6, 2013 | Class II | Z-2227-2013 | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
| Aug 6, 2013 | Class II | Z-2228-2013 | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
| Aug 6, 2013 | Class II | Z-2225-2013 | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
The 5 latest of 9 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 12 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K121018 (Smith & Nephew, Inc., 2012) has gone furthest, with 29 descendants of its own.
- 15 other devices also cite its predicate K053344.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
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 Haltux valgus repairs Media[ or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon…
Read the full statement (124 words)
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
Haltux valgus repairs
Media[ or lateral instability repairs/reconstructions
Achilles tendon 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082215 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082215: Osteoraptor Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082215
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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