510(k) Report

510(k) · Cleared

Cleared

LigaMetrics Suture Anchors

K171964510(k) TraditionalCleared Sep 19, 201781-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mortise Medical, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Sep 19, 2017 as substantially equivalent to K093897 (Smith & Nephew Inc., Endoscopy Div., 2010) and 3 other predicates after an 81-day review. Its family tree reaches back 6 generations to 1997.

Decided
Sep 19, 2017
Review
81 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K971723 (1997). 18 ancestors in all, the oldest K961555 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2006: 3 other ancestors2005: 1 other ancestor2004: 1 other ancestor2000: 2 other ancestors2003: 1 other ancestor2001: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestorReference device: K150438 · Force Fiber OrthoTape suture · Teleflexmedical, Inc. · 2015K971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 1997K051219 · Pushlock · Arthrex, Inc. · 2005K073509 · Twinfix PK FP Suture Anchor · Smith & Nephew, Inc. · 2008K093897 · Smith & Nephew Footprint Ultra PK Suture Anchor · Smith & Nephew Inc., Endoscopy Div. · 2010 · recalledK113274 · Footprint Ultra PK Suture Anchor · Smith & Nephew, Inc. · 2012K123579 · Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL · Smith & Nephew, Inc. · 201319952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 4 other ancestors5 generations back: 1 other ancestor K123579 · Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL · Smith & Nephew, Inc. · 2013K113274 · Footprint Ultra PK Suture Anchor · Smith & Nephew, Inc. · 2012K093897 · Smith & Nephew Footprint Ultra PK Suture Anchor · Smith & Nephew Inc., Endoscopy Div. · 2010 · recalledK073509 · Twinfix PK FP Suture Anchor · Smith & Nephew, Inc. · 2008K051219 · Pushlock · Arthrex, Inc. · 2005K971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 1997−50
  1. Root · 6 generations backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
  2. 5 generations backK051219 PushlockArthrex, Inc. · 2005
  3. 4 generations backK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
  4. 3 generations backK093897 Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
  5. 2 generations backK113274 Footprint Ultra PK Suture AnchorSmith & Nephew, Inc. · 2012
  6. 1 generation backK123579 Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc. · 2013
  7. This deviceK171964 LigaMetrics Suture AnchorsMortise Medical, LLC · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K971723Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc.1997—
−5K051219PushlockArthrex, Inc.2005—
−4K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc.2008—
−3K093897Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div.20102
−2K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc.2012—
−1K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc.2013—
0 (this device)K171964LigaMetrics Suture AnchorsMortise Medical, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200020
200110
200310
200410
200510
200630
201410
FIG. 1 — Lineage of K171964, 1997–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K093897Smith & Nephew Footprint Ultra PK Suture Anchor
Summary page 5
…(UHMWPE) 2.0mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc. Predicate Devices: The Smith & Nephew, Inc. Footprint Ultra PK Suture Anchor (K093897, K113274, K123579) serves as the primary predicate, and the MTP Solutions LLC Titanium Suture Anchor (K133229) serves as a refere…
Smith & Nephew Inc., Endoscopy Div.20102
*K113274Footprint Ultra PK Suture Anchor
Summary page 5
…2.0mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc. Predicate Devices: The Smith & Nephew, Inc. Footprint Ultra PK Suture Anchor (K093897, K113274, K123579) serves as the primary predicate, and the MTP Solutions LLC Titanium Suture Anchor (K133229) serves as a reference predi…
Smith & Nephew, Inc.2012—
*K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL
Summary page 5
…hoTape® (K150438) which is provided sterile packaged from Teleflex, Inc. Predicate Devices: The Smith & Nephew, Inc. Footprint Ultra PK Suture Anchor (K093897, K113274, K123579) serves as the primary predicate, and the MTP Solutions LLC Titanium Suture Anchor (K133229) serves as a reference predicate devi…
Smith & Nephew, Inc.2013—
*K133229Titanium Suture Anchor
Summary page 5
…The Smith & Nephew, Inc. Footprint Ultra PK Suture Anchor (K093897, K113274, K123579) serves as the primary predicate, and the MTP Solutions LLC Titanium Suture Anchor (K133229) serves as a reference predicate device. Technological Characteristics Comparison: The LigaMetrics Suture Anchors and the predic…
Mtp Solutions, LLC2014—
†K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc.2015—

Also cleared against K093897: 9 other devices →

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 20 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
  • 3 of the 18 ancestors have a recall of any class.
  • 9 other devices also cite its predicate K093897.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, 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 · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The LigaMetrics Suture Anchors are intended for use for the reattachment 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/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal…

Read the full statement (104 words)

The LigaMetrics Suture Anchors are intended for use for the reattachment 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/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, Iliotibial 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.

Hip: Distal row abductor tendon repair

Indications for use as stated in the FDA summary.

Also cleared against K093897

9 other devices cite the same predicate.

  • K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P…Suzhou Endophix Co., Ltd. · 2023
  • K182264ICONN Revolution Knotless Suture AnchorIconn Orthopedics, LLC · 2018
  • K173269KATOR Suture AnchorKator, LLC · 2018
  • K180274Ventix Link Knotless Anchor with InserterCayenne Medical, Inc. · 2018
  • K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc. · 2013
  • K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc. · 2012

More from Mortise Medical, LLC

2 FDA decisions under this applicant name. See the company

  • K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC · 2017

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K171964 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171964: LigaMetrics 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/K171964

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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