510(k) · Cleared
ClearedTac-Tite (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Core Essence Orthopaedics, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Mar 19, 2009 as substantially equivalent to K071520 (Core Essence Orthopaedics, LLC, 2007) after a 57-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Mar 19, 2009
- Review
- 57 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961555 (1996). 20 ancestors in all, the oldest K904436 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 3 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 1 generation backK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
- This deviceK090128 Tac-Tite (TM)Core Essence Orthopaedics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK111716 Knotless Suture Fixation SystemCore Essence Orthopaedics · 2011
Most influential descendants
Showing 1 of 1 · See all- K111716Knotless Suture Fixation SystemCore Essence Orthopaedics · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −3 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −2 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −1 | K071520 | Renovo Suture Anchors, Models 100-2001 Thru 100-5502X | Core Essence Orthopaedics, LLC | 2007 | — |
| 0 (this device) | K090128 | Tac-Tite (TM) | Core Essence Orthopaedics, Inc. | 2009 | — |
| +1 | K111716 | Knotless Suture Fixation System | Core Essence Orthopaedics | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 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 |
|---|---|---|---|
| * | K071520 | Renovo Suture Anchors, Models 100-2001 Thru 100-5502XSummary page 3…of the TAC-tite™ Suture Anchors is based on the equivalence in intended use, materials, operational principals, and indications to the reNOVO Suture Anchors covered by K071520. END OF 510(K) SUMMARY £ WEALTY ‘:‘o‘ “, 4, Vi UL ‘/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Se… | 2007 |
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 |
|---|---|---|---|
| K111716 | Knotless Suture Fixation System | 2011 | 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 13 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K111716 (Core Essence Orthopaedics, 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K071520.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
TAC-tite™ Suture Anchors are intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair
SLAP Lesion Repair
Acromio-Clavicular Separation
Roatator Cuff Repair
Capsule Repair
Biceps Tenodesis
Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction
Bicep Tendon Reconstruction
Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction
Ulnar / Radial Collateral Ligament Reconstruction
Collateral Ligaments around the PIP, DIP and MCP Joints
Flexor and Extensor Tendons
The Ankle and Foot:
Lateral Stabilization
Medial Stabilization
Achilles Tendon Repair / Reconstruction
Hallux Valgus Reconstruction
Mid and Rear Foot Reconstruction
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K090128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090128: Tac-Tite (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090128
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