510(k) Report

510(k) · Cleared

Cleared

Bonecam Suture Anchor

K193108510(k) SpecialCleared Mar 26, 2020139-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Valeris Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Mar 26, 2020 as substantially equivalent to K152255 (Valeris Medical, 2015) after a 139-day review. Its family tree reaches back 9 generations to 1996.

Decided
Mar 26, 2020
Review
139 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K961555 (1996). 39 ancestors in all, the oldest K915424 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2011: 2 other ancestors2009: 1 other ancestor2006: 5 other ancestors2012: 1 other ancestor2007: 4 other ancestors2004: 2 other ancestors2008: 1 other ancestor2005: 3 other ancestors1998: 2 other ancestors2001: 2 other ancestors2002: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestorReference device: K100006 · HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need · Riverpoint Medical · 2010 · recalledReference device: K190817 · HS Fiber · Riverpoint Medical · 2019K961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalled×2: 2 generations cleared close together, K053344 (2006), K061154 (2006) K071586 · Bioraptor 2.3 PK Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2007 · recalledK083635 · Smith & Nephew Biosure PK Interference Screw · Smith & Nephew Endoscopy, Inc. · 2009K133036 · Apollo Suture Anchor System and Titan Screws · Amendia, Inc. · 2014 · recalledK142230 · Apollo Suture Anchor System and Titan Screws · Valeris Medical · 2014 · recalledK152255 · BoneCam Suture Anchors · Valeris Medical · 20151990199520002005201020152020
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 4 other ancestors4 generations back: 6 other ancestors5 generations back: 5 other ancestors6 generations back: 6 other ancestors7 generations back: 3 other ancestors8 generations back: 2 other ancestors9 generations back: 3 other ancestors K152255 · BoneCam Suture Anchors · Valeris Medical · 2015K142230 · Apollo Suture Anchor System and Titan Screws · Valeris Medical · 2014 · recalledK133036 · Apollo Suture Anchor System and Titan Screws · Amendia, Inc. · 2014 · recalledK083635 · Smith & Nephew Biosure PK Interference Screw · Smith & Nephew Endoscopy, Inc. · 2009K071586 · Bioraptor 2.3 PK Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2007 · recalledK061154 · Kinsa Suture Anchor · Smith & Nephew, Inc. · 2006K053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996−50
  1. Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 5 generations between
  3. 3 generations backK133036 Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · Recalled
  4. 2 generations backK142230 Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · Recalled
  5. 1 generation backK152255 BoneCam Suture AnchorsValeris Medical · 2015
  6. This deviceK193108 Bonecam Suture AnchorValeris Medical, Inc. · 2020
Show all 9 generations
  1. Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 8 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 7 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 6 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
  5. 5 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
  6. 4 generations backK083635 Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
  7. 3 generations backK133036 Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · Recalled
  8. 2 generations backK142230 Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · Recalled
  9. 1 generation backK152255 BoneCam Suture AnchorsValeris Medical · 2015
  10. This deviceK193108 Bonecam Suture AnchorValeris Medical, Inc. · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−8K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−7K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−6K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006—
−5K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division20071
−4K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.2009—
−3K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.20141
−2K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical20141
−1K152255BoneCam Suture AnchorsValeris Medical2015—
0 (this device)K193108Bonecam Suture AnchorValeris Medical, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199610
199820
199910
200010
200120
200210
200420
200530
200650
200740
200810
200910
201120
201210
201410
FIG. 1 — Lineage of K193108, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K152255BoneCam Suture Anchors
Summary page 5
…er 21 CFR 888.3040 Product Code MBI Name of Predicate Device 510(k) # Manufacturer Bonecam Suture Anchor K152255 Valeris Medical Reference Predicate Device 510(k) # Manufacturer Riverpoint HS Fiber…
Valeris Medical2015—
†K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical20102
†K190817HS FiberRiverpoint Medical2019—

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 24 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
  • 9 of the 39 ancestors have a recall of any class.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

Shoulder • Rotator Cuff Repair • Bankart Repair • SLAP Lesion Repair • Biceps Tenodesis • Acormio-Clavicular Separation Repair • Deltoid Repair • Capsular Shift or Capsulolabral Reconstruction Hand and Wrist • Scapholunate Ligament Reconstruction • Carpal 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 Elbow • Biceps…

Read the full statement (138 words)

Shoulder

• Rotator Cuff Repair

• Bankart Repair

• SLAP Lesion Repair

• Biceps Tenodesis

• Acormio-Clavicular Separation Repair

• Deltoid Repair

• Capsular Shift or Capsulolabral Reconstruction

Hand and Wrist

• Scapholunate Ligament Reconstruction

• Carpal 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

Elbow

• Biceps Tendon Reattachment

• Ulnar or Radial Collateral Ligament Reconstruction

Hip

• Capsular Repair

• Acetabular Labral Repair

Foot and Ankle

• Lateral stabilization

• Medial stabilization

• Achilles tendon repair

• Metatarsal ligament repair

• Hallux valgus reconstruction

• Digital tendon transfers

• Mid-foot reconstruction

Knee

• Medial collateral ligament repair

• Lateral collateral ligament repair

• Posterior oblique ligament repair

• Illiotibial band tenodesis reconstruction

• Patellar ligament/tendon repair

Indications for use as stated in the FDA summary.

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K193108 · printed Nov 4, 2026

Cite this page

510(k) Report. “K193108: Bonecam 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/K193108

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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