510(k) · Cleared
Recalled · Class II · 2020Smith & Nephew Footprint Ultra PK Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Inc., Endoscopy Div. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 4, 2010 as substantially equivalent to K073509 (Smith & Nephew, Inc., 2008) and 1 other predicate after a 76-day review. Its family tree reaches back 3 generations to 1997. 29 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 4, 2010
- Review
- 76 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971723 (1997). 4 ancestors in all. 29 later devices descend from it, 10 citing it directly.
- Root · 3 generations backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
- 2 generations backK051219 PushlockArthrex, Inc. · 2005
- 1 generation backK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
- This deviceK093897 Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010
- Descendant · cites it directly · 16 of its ownK113274 Footprint Ultra PK Suture AnchorSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK112876 Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek…Cayenne Medical, 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
- Descendant · cites it directly · 6 of its ownK122314 Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc. · 2012 · cites it directly16descendants
- K112876Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM)…Cayenne Medical, Inc. · 2011 · cites it directly7descendants
- K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · 2 generations on6descendants
- K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc. · 2012 · cites it directly6descendants
- K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971723 | Fastak Suture Anchor (11.7MM)/(7.5MM) | Arthrex, Inc. | 1997 | — |
| −2 | K051219 | Pushlock | Arthrex, Inc. | 2005 | — |
| −1 | K073509 | Twinfix PK FP Suture Anchor | Smith & Nephew, Inc. | 2008 | — |
| 0 (this device) | K093897 | Smith & Nephew Footprint Ultra PK Suture Anchor | Smith & Nephew Inc., Endoscopy Div. | 2010 | — |
| +1 | K113274 | Footprint Ultra PK Suture Anchor | Smith & Nephew, Inc. | 2012 | — |
| +1 | K112876 | Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink… | Cayenne Medical, Inc. | 2011 | — |
| +2 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01… | Smith & Nephew, Inc. | 2015 | 2 |
| +1 | K122314 | Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only | Cayenne Medical, Inc. | 2012 | — |
| +2 | K180951 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K073509 | Twinfix PK FP Suture AnchorSummary page 1…bstantially equivalent in Intended Use and fundamental scientific technology to the legally marketed Smith & Nephew Twinfix FP PK Suture Anchor cleared via K073509 and the Arthrex PushLock cleared via K05 1219. E. Description of Device The FOOTPRINT Ultra PK is a suture anchor… | 2008 |
| * | K051219 | PushlockSummary page 1…ndamental scientific technology to the legally marketed Smith & Nephew Twinfix FP PK Suture Anchor cleared via K073509 and the Arthrex PushLock cleared via K05 1219. E. Description of Device The FOOTPRINT Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone).… | 2005 |
What descends from it? (29)
See all 2910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113274 | Footprint Ultra PK Suture Anchor | 2012 | 16 |
| K112876 | Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM)… | 2011 | 7 |
| K122314 | Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only | 2012 | 6 |
| K123579 | Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL | 2013 | 4 |
| K173269 | KATOR Suture Anchor | 2018 | 2 |
| K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture… | 2023 | 0 |
| K182264 | ICONN Revolution Knotless Suture Anchor | 2018 | 0 |
| K180274 | Ventix Link Knotless Anchor with Inserter | 2018 | 0 |
| K171964 | LigaMetrics Suture Anchors | 2017 | 0 |
| K110538 | Pro Fixation System | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2020 | Class II | Z-1757-2020 | Package design/selection | Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach. |
| Mar 17, 2020 | Class II | Z-1756-2020 | Package design/selection | Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K113274 (Smith & Nephew, Inc., 2012) has gone furthest, with 16 descendants of its own.
- 5 other devices also cite its predicate K073509.
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. 2010, 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?
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is intended for use for the reattachmnent Of Soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acrornio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction. Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot…
Read the full statement (103 words)
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is intended for use for the reattachmnent Of Soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acrornio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, lliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093897: Smith & Nephew Footprint Ultra PK Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093897
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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