510(k) · Cleared
ClearedTeKBrace Knotless Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theramicro · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 6, 2026 as substantially equivalent to K203495 (Arthrex, Inc., 2021) and 4 other predicates after a 113-day review. Its family tree reaches back 13 generations to 1979.
- Decided
- Mar 6, 2026
- Review
- 113 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K792022 (1979). 144 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations between
- 3 generations backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- 2 generations backK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
- 1 generation backK230435 Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc. · 2023
- This deviceK253538 TeKBrace Knotless AnchorTheramicro · 2026
Show all 13 generations
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 12 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 11 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 10 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 9 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 8 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 7 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 6 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 5 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 4 generations backK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- 3 generations backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- 2 generations backK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
- 1 generation backK230435 Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc. · 2023
- This deviceK253538 TeKBrace Knotless AnchorTheramicro · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −12 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −11 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −10 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −9 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −8 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −7 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| −6 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| −5 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| −4 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| −3 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
| −2 | K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021 | 1 |
| −1 | K230435 | Arthrex 3.9 mm SwiveLock Anchor | Arthrex, Inc. | 2023 | — |
| 0 (this device) | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 10 | 0 |
| 1997 | 6 | 0 |
| 1998 | 6 | 0 |
| 1999 | 10 | 0 |
| 2000 | 8 | 0 |
| 2001 | 13 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203495 | Arthrex SwiveLock AnchorSummary page 5…bone fixation fastener) Panel: Orthopedic Product Code: MBI Primary Predicate: Arthrex Swivelok Anchors – K203495 Additional Predicates: In2Bones Hercules Suture Anchor System – K201636 Artelon ATL A… | 2021 |
| * | K201636 | Hercules Suture Anchor SystemSummary page 5…Product Code: MBI Primary Predicate: Arthrex Swivelok Anchors – K203495 Additional Predicates: In2Bones Hercules Suture Anchor System – K201636 Artelon ATL Anchors – K200503 Device Description: The TeKBrace Knotless Anchors are part of th… | 2020 |
| * | K200503 | ATL AnchorsSummary page 5…hrex Swivelok Anchors – K203495 Additional Predicates: In2Bones Hercules Suture Anchor System – K201636 Artelon ATL Anchors – K200503 Device Description: The TeKBrace Knotless Anchors are part of the TeKBrace System which is intended for the fixation of soft ti… | 2020 |
| * | K101823 | Arthrex Swivelock AnchorsSummary page 6…mponents are substantially equivalent to the predicate In2Bones Hercules Suture Anchors cleared under K201636, Arthrex SwiveLok Anchors (primary predicate) cleared under K101823, K203435, K230435 and Artelon ATL Anchors cleared under K200503. The subject components are similar in indications, geometry, and… | 2011 |
| Kept off the family tree | K203435 | FDA’s K203435 is Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope… Our reading of the summary gave K203435, FDA’s number for Nihon Kohden Life Scope G5 Bedside Monitoring System… (Nihon Kohden Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Arthrex SwiveLok Anchors”. Kept off the family tree. Summary page 6…are substantially equivalent to the predicate In2Bones Hercules Suture Anchors cleared under K201636, Arthrex SwiveLok Anchors (primary predicate) cleared under K101823, K203435, K230435 and Artelon ATL Anchors cleared under K200503. The subject components are similar in indications, geometry, and material… | 2021 |
| * | K230435 | Arthrex 3.9 mm SwiveLock AnchorSummary page 6…antially equivalent to the predicate In2Bones Hercules Suture Anchors cleared under K201636, Arthrex SwiveLok Anchors (primary predicate) cleared under K101823, K203435, K230435 and Artelon ATL Anchors cleared under K200503. The subject components are similar in indications, geometry, and materials to the… | 2023 |
| † | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | 2025 |
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 47 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 22 of the 144 ancestors have a recall of any class.
- 10 other devices also cite its predicate K203495.
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. 2026, 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?
TheraMicro TeKBrace Knotless Anchors are intended for use in the following applications: Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus reconstruction, Midfoot reconstruction , Metatarsal Ligament/Tendon Repair, and…
Read the full statement (166 words)
TheraMicro TeKBrace Knotless Anchors are intended for use in the following applications:
Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation
and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus
reconstruction, Midfoot reconstruction , Metatarsal Ligament/Tendon Repair, and Bunionectomy.
Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 Only), Medial collateral and Lateral collateral ligament
repair, Patellar tendon repair and Posterior oblique ligament repair, Extra Capsular Reconstruction, llliotibial
Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Quadriceps Tendon Repair (4.75 Only),
Meniscal Root Repair (4.75 Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair
(4.75-5.5 only), MPFL Repair/Reconstruction (3.9 Only)
Hand and Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament and Ulnar
collateral ligament reconstruction.
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament
reconstruction.
Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 - 5.5 mm only), and Proximal
Hamstring Repair (4.75 - 5.5 only).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253538 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253538: TeKBrace Knotless Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253538
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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