510(k) · Cleared
ClearedResponsive Arthroscopy Wedge Push-In 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 Jan 18, 2019 as substantially equivalent to K140855 (Arthrex, Inc., 2014) and 4 other predicates after a 269-day review. Its family tree reaches back 11 generations to 1991. 2 later devices descend from it.
- Decided
- Jan 18, 2019
- Review
- 269 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K911837 (1991). 100 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 7 generations between
- 3 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 2 generations backK090835 Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
- 1 generation backK112965 Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011 · Recalled
- This deviceK181076 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
- Descendant · cites it directly · 1 of its ownK190446 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
- Descendant · cites it directly · 0 of its ownK233258 Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC · 2023
Show all 11 generations
- Root · 11 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 10 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 9 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 8 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 7 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 6 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 5 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 4 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 3 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 2 generations backK090835 Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
- 1 generation backK112965 Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011 · Recalled
- This deviceK181076 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −10 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −9 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −8 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −7 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −6 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −5 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −4 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −3 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| −2 | K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR | Linvatec Corp. | 2009 | — |
| −1 | K112965 | Nano Suture Anchor | Linvatec Corporation D/B/A Conmed Linvatec | 2011 | 6 |
| 0 (this device) | 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 | — |
| +1 | 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 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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? (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 |
|---|---|---|---|
| * | K140855 | Arthrex Suturetak Suture AnchorsSummary page 4…he predicate devices in all facets including: function, design, performance, material, and intended use. Primary Predicate: Arthrex SutureTak Suture Anchors: K140855 Additional Predicates: Arthrex PushLock Anchors: K101679 Arthrex Knotless SutureTak Suture… | 2014 |
| * | K101679 | Arthrex Pushlock AnchorsSummary page 4…erformance, material, and intended use. Primary Predicate: Arthrex SutureTak Suture Anchors: K140855 Additional Predicates: Arthrex PushLock Anchors: K101679 Arthrex Knotless SutureTak Suture Anchor: K171020 ConMed Linvatec NAN… | 2010 |
| * | K171020 | Arthrex Knotless SutureTak AnchorSummary page 4…utureTak Suture Anchors: K140855 Additional Predicates: Arthrex PushLock Anchors: K101679 Arthrex Knotless SutureTak Suture Anchor: K171020 ConMed Linvatec NANO Suture Anchor: K112965 Smith & Nephew BIORAPTOR… | 2017 |
| * | K112965 | Nano Suture AnchorSummary page 4…shLock Anchors: K101679 Arthrex Knotless SutureTak Suture Anchor: K171020 ConMed Linvatec NANO Suture Anchor: K112965 Smith & Nephew BIORAPTOR Knotless Suture Anchor: K121018 The Wedge Push-In Suture Anchor is of sim… | 2011 |
| * | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSummary page 4…Anchor: K171020 ConMed Linvatec NANO Suture Anchor: K112965 Smith & Nephew BIORAPTOR Knotless Suture Anchor: K121018 The Wedge Push-In Suture Anchor is of similar size and made from the same basic materials as the predicate devices. The device h… | 2012 |
| † | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 11 of the 100 ancestors have a recall of any class.
- Of its descendants, K190446 (Responsive Arthroscopy, LLC, 2019) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K140855.
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. 2019, 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 Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow 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 Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization…
Read the full statement (157 words)
The Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow 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 Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair.
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/K181076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181076: Responsive Arthroscopy Wedge Push-In 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/K181076
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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