510(k) · Cleared
ClearedGMReis Suture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GM Dos Reis Industria e Comercio Ltda. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 4, 2025 as substantially equivalent to K150648 (Arthrex, Inc., 2015) and 4 other predicates after a 74-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it.
- Decided
- Nov 4, 2025
- Review
- 74 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K961555 (1996). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations between
- 3 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 2 generations backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
- 1 generation backK251145 Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025
- This deviceK252664 GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025
- Descendant · cites it directly · 0 of its ownK254188 Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026
Show all 10 generations
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 9 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 8 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 7 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 6 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 5 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 4 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- 3 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 2 generations backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
- 1 generation backK251145 Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025
- This deviceK252664 GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025
Most influential descendants
Showing 1 of 1 · See all- K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −9 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −8 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −7 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −6 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −5 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −4 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| −3 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| −2 | K151092 | Arthrex Short Suture Anchors | Arthrex, Inc. | 2016 | — |
| −1 | K251145 | Arthrex PushLock Suture Anchors | Arthrex, Inc. | 2025 | — |
| 0 (this device) | K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | 2025 | — |
| +1 | K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (5)
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 |
|---|---|---|---|
| * | K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Summary page 5…ch we are claiming “Substantial Equivalence” are the following: Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm (K150648) (Primary predicate device). Arthrex PushLock Suture Anchors (K251145) (Additional predicate device). Arthrex 2.5 mm Tenodesis Sc… | 2015 |
| * | K251145 | Arthrex PushLock Suture AnchorsSummary page 5…x DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm (K150648) (Primary predicate device). Arthrex PushLock Suture Anchors (K251145) (Additional predicate device). Arthrex 2.5 mm Tenodesis Screw (K183395) (Additional predicate device). SwiveLock Anchors (K10182… | 2025 |
| * | K183395 | Arthrex 2.5 mm Tenodesis ScrewSummary page 5…uture Anchor, 3.5 x 13.5mm (K150648) (Primary predicate device). Arthrex PushLock Suture Anchors (K251145) (Additional predicate device). Arthrex 2.5 mm Tenodesis Screw (K183395) (Additional predicate device). SwiveLock Anchors (K101823) (Additional predicate device). Arthrex Tenodesis Screw Family (K05172… | 2019 |
| * | K101823 | Arthrex Swivelock AnchorsSummary page 5…ice). Arthrex PushLock Suture Anchors (K251145) (Additional predicate device). Arthrex 2.5 mm Tenodesis Screw (K183395) (Additional predicate device). SwiveLock Anchors (K101823) (Additional predicate device). Arthrex Tenodesis Screw Family (K051726) (Additional predicate device). EXPERT - Flexible Joint F… | 2011 |
| * | K051726 | Arthrex Tenodesis FamilySummary page 5…vice). Arthrex 2.5 mm Tenodesis Screw (K183395) (Additional predicate device). SwiveLock Anchors (K101823) (Additional predicate device). Arthrex Tenodesis Screw Family (K051726) (Additional predicate device). EXPERT - Flexible Joint Fixation System - GMReis (K242311) (Reference device). IV. Device Descr… | 2005 |
| † | K242311 | EXPERT - Flexible Joint Fixation System | 2024 |
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 |
|---|---|---|---|
| K254188 | Meniscus Versaflex | 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 29 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K254188 (GM Dos Reis Industria e Comercio Ltda., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K150648.
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. 2025, 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 GMReis Suture Anchors is intended to be used for soft tissue reattachment 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.…
Read the full statement (140 words)
The GMReis Suture Anchors is intended to be used for soft tissue reattachment 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, 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, 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/K252664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252664: GMReis Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252664
Report an extraction error
Are you the manufacturer?
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