510(k) · Cleared
ClearedFootprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL
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 Jan 23, 2013 as substantially equivalent to K113274 (Smith & Nephew, Inc., 2012) and 1 other predicate after a 65-day review. Its family tree reaches back 5 generations to 1997. 4 later devices descend from it.
- Decided
- Jan 23, 2013
- Review
- 65 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971723 (1997). 10 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
- 4 generations backK051219 PushlockArthrex, Inc. · 2005
- 3 generations backK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
- 2 generations backK093897 Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
- 1 generation backK113274 Footprint Ultra PK Suture AnchorSmith & Nephew, Inc. · 2012
- This deviceK123579 Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK173269 KATOR Suture AnchorKator, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK242477 Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK182736 OIC Suture Anchor SystemThe Orthopaedic Implant Company · 2018
- Descendant · cites it directly · 0 of its ownK171964 LigaMetrics Suture AnchorsMortise Medical, LLC · 2017
Most influential descendants
Showing 4 of 4 · See all- K173269KATOR Suture AnchorKator, LLC · 2018 · cites it directly2descendants
- K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025 · 2 generations on0descendants
- K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company · 2018 · 2 generations on0descendants
- K171964LigaMetrics Suture AnchorsMortise Medical, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971723 | Fastak Suture Anchor (11.7MM)/(7.5MM) | Arthrex, Inc. | 1997 | — |
| −4 | K051219 | Pushlock | Arthrex, Inc. | 2005 | — |
| −3 | K073509 | Twinfix PK FP Suture Anchor | Smith & Nephew, Inc. | 2008 | — |
| −2 | K093897 | Smith & Nephew Footprint Ultra PK Suture Anchor | Smith & Nephew Inc., Endoscopy Div. | 2010 | 2 |
| −1 | K113274 | Footprint Ultra PK Suture Anchor | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K123579 | Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL | Smith & Nephew, Inc. | 2013 | — |
| +1 | K173269 | KATOR Suture Anchor | Kator, LLC | 2018 | — |
| +2 | K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. | 2025 | — |
| +2 | K182736 | OIC Suture Anchor System | The Orthopaedic Implant Company | 2018 | — |
| +1 | K171964 | LigaMetrics Suture Anchors | Mortise Medical, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K113274 | Footprint Ultra PK Suture AnchorSummary page 1…, SL is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: K113274 FOOTPRINT Ultra PK Suture Anchor (cleared March 6, 2012) K… | 2012 |
| * | K093897 | Smith & Nephew Footprint Ultra PK Suture AnchorSummary page 1…ercial distribution: K113274 FOOTPRINT Ultra PK Suture Anchor (cleared March 6, 2012) K093897 SMITH & NEPHEW FOOTPRINT Ultra PK Suture Anchor (cleared March 4, 2010)… | 2010 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K173269 (Kator, LLC, 2018) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K113274.
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. 2013, 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, Inc. FOOTPRINT Ultra PK< Suture Anchor, SL is intended for use in the fixation of
soft tissue to bone for the following indications:
Shoulder
Rotator Cuff repair, Bankart repair, Slap lesion repair, Biceps Tenodesis, Acromio-Clavicular separation,
Deltoid repair, and Capsular shift or capsulolabral reconstruction
Foot and Ankle
Lateral stabilization, Medial stabilization, Achilles tendon repair, H-allux valgus reconstruction, Mid-foot
reconstruction, Metatarsal ligament repair
Knee
Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior
oblique ligament repair, Iliotibial band tenodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123579: Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123579
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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