510(k) · Cleared
ClearedShadow Knotless All-Suture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Responsive Arthroscopy, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 23, 2023 as substantially equivalent to K230094 (Responsive Arthroscopy, LLC, 2023) and 2 other predicates after a 25-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Oct 23, 2023
- Review
- 25 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K911837 (1991). 115 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 backK112965 Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011 · Recalled
- 2 generations backK181076 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
- 1 generation backK190446 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
- This deviceK233258 Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC · 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 backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 4 generations backK090835 Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
- 3 generations backK112965 Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011 · Recalled
- 2 generations backK181076 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
- 1 generation backK190446 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
- This deviceK233258 Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC · 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 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| −4 | K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR | Linvatec Corp. | 2009 | — |
| −3 | K112965 | Nano Suture Anchor | Linvatec Corporation D/B/A Conmed Linvatec | 2011 | 6 |
| −2 | K181076 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Responsive Arthroscopy, LLC | 2019 | — |
| −1 | K190446 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Responsive Arthroscopy, LLC | 2019 | — |
| 0 (this device) | K233258 | Shadow Knotless All-Suture Anchors | Responsive Arthroscopy, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K230094 | Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsSummary page 5…21 CFR 888.3040 Predicate Device: Responsive Arthroscopy Mini Stealth All-Suture Anchors (K230094) Additional Predicate Devices: Responsive Arthroscopy Wedge Push-In Suture Anchors… | 2023 |
| * | K190446 | Responsive Arthroscopy Wedge Push-In Suture AnchorsSummary page 5…(K230094) Additional Predicate Devices: Responsive Arthroscopy Wedge Push-In Suture Anchors (K190446, K181076) The predicate devices have not been subject to any design-related recalls. DEVICE DESCRIPTION: The Shadow Knotl… | 2019 |
| * | K181076 | Responsive Arthroscopy Wedge Push-In Suture AnchorsSummary page 5…(K230094) Additional Predicate Devices: Responsive Arthroscopy Wedge Push-In Suture Anchors (K190446, K181076) The predicate devices have not been subject to any design-related recalls. DEVICE DESCRIPTION: The Shadow Knotless All-S… | 2019 |
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 9 companies; a new generation was cleared every 1.6 years on median.
- 12 of the 115 ancestors have a recall of any class.
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 Shadow Knotless All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux…
Read the full statement (138 words)
The Shadow Knotless All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233258: Shadow Knotless All-Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233258
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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