510(k) · Cleared
ClearedStativ® Knotted UHMWPE Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthium Medtech Limited · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 22, 2023 as substantially equivalent to K203268 (Arthrex, Inc., 2020) and 1 other predicate after an 85-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Mar 22, 2023
- Review
- 85 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K911837 (1991). 102 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 9 generations between
- 3 generations backK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- 2 generations backK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014
- 1 generation backK192709 Fixone All Suture AnchorAju Pharm Co., Ltd. · 2020
- This deviceK223889 Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited · 2023
Show all 13 generations
- Root · 13 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 12 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 11 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 10 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 9 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 8 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 7 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 6 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 5 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 4 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 3 generations backK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- 2 generations backK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014
- 1 generation backK192709 Fixone All Suture AnchorAju Pharm Co., Ltd. · 2020
- This deviceK223889 Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −12 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −11 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −10 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −9 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −8 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −7 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −6 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −5 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| −4 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| −3 | K131035 | Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM | Linvatec Corporation D/B/A Conmed Linvatec | 2013 | — |
| −2 | K133224 | Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2… | Conmed Corporation | 2014 | — |
| −1 | K192709 | Fixone All Suture Anchor | Aju Pharm Co., Ltd. | 2020 | — |
| 0 (this device) | K223889 | Stativ® Knotted UHMWPE Suture Anchor | Healthium Medtech Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 12 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K203268 | Arthrex FiberTak Suture AnchorSummary page 5…Table 1: Predicate details Device Name 510(k) Number Arthrex FiberTak Suture Anchor (Primary) K203268 Fixone All Suture Anchor (Secondary) K192709 Device Description The STATIV® Knotted UHMWPE… | 2020 |
| * | K192709 | Fixone All Suture AnchorSummary page 5…510(k) Number Arthrex FiberTak Suture Anchor (Primary) K203268 Fixone All Suture Anchor (Secondary) K192709 Device Description The STATIV® Knotted UHMWPE Suture Anchor is a fixation device intended to provide secure fi… | 2020 |
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 32 years and passes through 11 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 102 ancestors have a recall of any class.
- 5 other devices also cite its predicate K203268.
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 STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures: 1. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. 2. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair…
Read the full statement (150 words)
The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures:
1. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
2. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction.
3. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
4. 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).
5. Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction.
6. Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon Repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223889: Stativ® Knotted UHMWPE Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223889
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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