510(k) · Cleared
ClearedSuture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gm Dos Reis Industria E Comerico Ltda. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 2, 2023 as substantially equivalent to K180118 (Arthrex, Inc., 2018) after a 303-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Aug 2, 2023
- Review
- 303 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K961555 (1996). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 4 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 3 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 2 generations backK112237 Microsuture AnchorsArthrex, Inc. · 2011
- 1 generation backK180118 Arthrex NanoSuture AnchorArthrex, Inc. · 2018 · Recalled
- This deviceK223114 Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda. · 2023
- Descendant · cites it directly · 0 of its ownK253027 Anchor with Fiber Wire and Disposable InserterOrtobio S.A. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −4 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −3 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −2 | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
| −1 | K180118 | Arthrex NanoSuture Anchor | Arthrex, Inc. | 2018 | 1 |
| 0 (this device) | K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Gm Dos Reis Industria E Comerico Ltda. | 2023 | — |
| +1 | K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K180118 | Arthrex NanoSuture AnchorSummary page 4…n Regulation 21 CFR 888.3040, Class II Review Panel Orthopedic PREDICATE DEVICE INFORMATION Predicate Devices K180118 – Arthrex NanoSuture Anchor - Arthrex, Inc. Reference Devices K112237 – MicroSuture Anchors - Arthrex, Inc.… | 2018 |
| † | K112237 | Microsuture Anchors | 2011 |
| † | K003816 | Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM, Arthrex Titanium… | 2001 |
| † | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | 2006 |
| † | K110879 | Biomet Sports Medicine Juggerknot (TM) Mini Soft Anchor | 2011 |
| † | K172612 | FiberTak DX | 2017 |
| † | K151230 | Arthrex FiberTak Anchors | 2015 |
| † | K181769 | Arthrex FiberTak Suture Anchor | 2018 |
| † | K200332 | EXPERT - Joint Fixation System | 2020 |
| † | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253027 | Anchor with Fiber Wire and Disposable Inserter | 2026 | 0 |
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 27 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K253027 (Ortobio S.A., 2026) has gone furthest, with 0 descendants of its own.
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. 2023, 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 Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular…
Read the full statement (150 words)
The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular repair, acetabular labral repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223114: Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223114
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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