510(k) · Cleared
ClearedNanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanova Biomaterials, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on May 5, 2017 as substantially equivalent to K082810 (Arthrex, Inc., 2009) and 1 other predicate after a 129-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- May 5, 2017
- Review
- 129 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K961555 (1996). 40 ancestors in all, the oldest K925573 (1993). No later device cites it as a predicate yet.
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations between
- 3 generations backK101459 Osteoraptor II Suture Anchor or to BE Determined Model: 72202764…Smith & Nephew, Inc. · 2011
- 2 generations backK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013
- 1 generation backK151105 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK163672 Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017
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 backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 4 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- 3 generations backK101459 Osteoraptor II Suture Anchor or to BE Determined Model: 72202764…Smith & Nephew, Inc. · 2011
- 2 generations backK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013
- 1 generation backK151105 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK163672 Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017
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 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −4 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| −3 | K101459 | Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765… | Smith & Nephew, Inc. | 2011 | — |
| −2 | K123393 | Healicoil Suture Anchor with Regenesorb | Smith & Nephew, Inc. | 2013 | — |
| −1 | K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and… | Smith & Nephew, Inc. | 2015 | 40 |
| 0 (this device) | 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 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 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? (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 |
|---|---|---|---|
| * | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Summary page 5…Class II 9) Predicated Devices: NanovaTM Screw-In Suture Anchor is believed to be substantially equivalent to BioComposite Corkscrew (K082810). NanovaTM Push-In Suture Anchor is believed to be substantially equivalent to BioComposite PushLock (K082810) and… | 2009 |
| * | K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Summary page 5…omposite Corkscrew (K082810). NanovaTM Push-In Suture Anchor is believed to be substantially equivalent to BioComposite PushLock (K082810) and Osteoraptor (K151105). 10) Indication for Use: NanovaTM Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the sho… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 15 of the 40 ancestors have a recall of any class.
- 12 other devices also cite its predicate K082810.
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. 2017, 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?
Nanova Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus…
Read the full statement (234 words)
Nanova Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Nanova Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163672 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163672: Nanova Screw-In Suture Anchor, Nanova Push-In 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/K163672
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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