510(k) Report

510(k) · Cleared

Cleared

Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)

K243665510(k) TraditionalCleared Jan 31, 202565-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

ZheJiang Decans Medical Devices Co., Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jan 31, 2025 as substantially equivalent to K061665 (Arthrex, Inc., 2006) and 4 other predicates after a 65-day review. Its family tree reaches back 10 generations to 1996.

Decided
Jan 31, 2025
Review
65 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K961555 (1996). 47 ancestors in all, the oldest K941364 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 3 other ancestors2010: 4 other ancestors2006: 3 other ancestors2009: 3 other ancestors2005: 3 other ancestors2004: 1 other ancestor2002: 2 other ancestors2000: 3 other ancestors1998: 1 other ancestor2011: 2 other ancestors2008: 2 other ancestors2007: 3 other ancestors2001: 4 other ancestors2003: 1 other ancestor1994: 1 other ancestor1997: 1 other ancestorK961555 · 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) K070908 · Smith & Nephew Kinsa RC Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2007K072785 · Twinfix FT PK · Smith & Nephew Inc., Endoscopy Division · 2007×2: 2 generations cleared close together, K093228 (2009), K100159 (2010) K112526 · Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors · Smith & Nephew, Inc. · 2012K152566 · PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors · Smith & Nephew, Inc. · 2015 · recalled1990200020102020
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 11 other ancestors3 generations back: 11 other ancestors4 generations back: 8 other ancestors5 generations back: 3 other ancestors K152566 · PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors · Smith & Nephew, Inc. · 2015 · recalledK112526 · Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors · Smith & Nephew, Inc. · 2012K100159 · Smith and Nephew Twinfix Ultra TI Suture Anchor · Smith & Nephew Inc., Endoscopy Div. · 2010 · recalledK093228 · Smith & Nephew Twinfix Ultra PK Suture Anchor · Smith & Nephew, Inc. · 2009K072785 · Twinfix FT PK · Smith & Nephew Inc., Endoscopy Division · 2007K070908 · Smith & Nephew Kinsa RC Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2007K061154 · 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. · 1996−10−50
  1. Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 6 generations between
  3. 3 generations backK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
  4. 2 generations backK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
  5. 1 generation backK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
  6. This deviceK243665 Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK…ZheJiang Decans Medical Devices Co., Ltd. · 2025
Show all 10 generations
  1. Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 9 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 8 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 7 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
  5. 6 generations backK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
  6. 5 generations backK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
  7. 4 generations backK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
  8. 3 generations backK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
  9. 2 generations backK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
  10. 1 generation backK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
  11. This deviceK243665 Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK…ZheJiang Decans Medical Devices Co., Ltd. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−9K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−8K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−7K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006—
−6K070908Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division2007—
−5K072785Twinfix FT PKSmith & Nephew Inc., Endoscopy Division2007—
−4K093228Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc.2009—
−3K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div.20104
−2K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.2012—
−1K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01…Smith & Nephew, Inc.20152
0 (this device)K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor…ZheJiang Decans Medical Devices Co., Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199710
199810
200030
200140
200220
200310
200410
200530
200630
200730
200820
200930
201040
201120
201230
FIG. 1 — Lineage of K243665, 1996–2025Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT
Summary page 7
…Suture Anchor Classification Name:fastener, fixation, nondegradable, soft tissue Regulatory Class: Class II Product Code:MBI 3.PREDICATE DEVICE Primary Predicate Device K061665-Arthrex Corkscrew FT by ARTHREX, INC Additional Predicate Devices K152566-TWINFIX Ultra PK Suture Anchor by SMITH & NEPHEW, INC.…
Arthrex, Inc.2006—
*K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…
Summary page 7
…tissue Regulatory Class: Class II Product Code:MBI 3.PREDICATE DEVICE Primary Predicate Device K061665-Arthrex Corkscrew FT by ARTHREX, INC Additional Predicate Devices K152566-TWINFIX Ultra PK Suture Anchor by SMITH & NEPHEW, INC. K113294-HEALICOIL PK Suture Anchor by SMITH & NEPHEW, INC. K101679-Arthrex…
Smith & Nephew, Inc.20152
*K113294Smith & Nephew Healicoil PK Suture Anchor
Summary page 7
…DEVICE Primary Predicate Device K061665-Arthrex Corkscrew FT by ARTHREX, INC Additional Predicate Devices K152566-TWINFIX Ultra PK Suture Anchor by SMITH & NEPHEW, INC. K113294-HEALICOIL PK Suture Anchor by SMITH & NEPHEW, INC. K101679-Arthrex PushLock Anchors by ARTHREX, INC K063479-Arthrex 2.5mm PushLoc…
Smith & Nephew, Inc.2012—
*K101679Arthrex Pushlock Anchors
Summary page 7
…FT by ARTHREX, INC Additional Predicate Devices K152566-TWINFIX Ultra PK Suture Anchor by SMITH & NEPHEW, INC. K113294-HEALICOIL PK Suture Anchor by SMITH & NEPHEW, INC. K101679-Arthrex PushLock Anchors by ARTHREX, INC K063479-Arthrex 2.5mm PushLock Anchors by ARTHREX, INC 4.DEVICE DESCRIPTION The Crius P…
Arthrex, Inc.2010—
*K063479Arthrex Pushlock
Summary page 7
…152566-TWINFIX Ultra PK Suture Anchor by SMITH & NEPHEW, INC. K113294-HEALICOIL PK Suture Anchor by SMITH & NEPHEW, INC. K101679-Arthrex PushLock Anchors by ARTHREX, INC K063479-Arthrex 2.5mm PushLock Anchors by ARTHREX, INC 4.DEVICE DESCRIPTION The Crius PEEK Suture Anchor System is a soft-tissue to bone…
Arthrex, Inc.2006—

Also cleared against K061665: 13 other devices →

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 29 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
  • 10 of the 47 ancestors have a recall of any class.
  • 13 other devices also cite its predicate K061665.

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. 2025, 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?

The Crius PEEK Suture Anchor System is intended for the fixation of soft tissue to bone in the foot,ankle,hand,wrist,elbow,knee,hip and shoulder. Crius PEEK Suture Anchor System (Thread-Fix Anchor) Shoulder: Rotator Cuff Repairs 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…

Read the full statement (376 words)

The Crius PEEK Suture Anchor System is intended for the fixation of soft tissue to bone in the foot,ankle,hand,wrist,elbow,knee,hip and shoulder.

Crius PEEK Suture Anchor System (Thread-Fix Anchor)

Shoulder:

Rotator Cuff Repairs

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

Midfoot reconstruction

Metatarsal Ligament Repair

Knee:

Anterior Cruciate Ligament Repair

Medial Collateral Ligament Repair

Lateral Collateral Ligament Repair

Patellar Tendon Repair

Posterior Oblique Ligament Repair

lliotibial Band Tenodesis

Elbow:

Biceps Tendon Reattachment

Ulnar or Radial Collateral Ligament Reconstruction

Hip:

Capsular Repair

Acetabular labral repair.

Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor)

Shoulder:

Rotator Cuff Repairs

Bankart Repair

SLAP Lesion Repair

Biceps Tenodesis

Acromio-Clavicular Separation Repair

Deltoid Repair

Capsular Shift or Capsulolabral Reconstruction

Foot/ Ankle:

Hallux valgus repairs

Medial or lateral instability repairs/reconstructions

Achilles tendon repairs/reconstructions

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

Knee:

Medial collateral ligament repair

Lateral collateral ligament repair

Posterior oblique ligament repair

lliotibial band tenodesis

Patellar realignment and tendon repairs

Elbow:

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

Biceps tendon reattachment

Hip:

Abductor tendon repair

Crius PEEK Suture Anchor System (Helicoil Anchor)

Shoulder:

Rotator Cuff Repairs

Bankart Repair

SLAP Lesion Repair

Biceps Tenodesis

Acromio-Clavicular Separation Repair

Deltoid Repair

Capsular Shift or Capsulolabral Reconstruction

Foot/ Ankle:

Hallux valgus repairs

Medial or lateral instability repairs/reconstructions

Achilles tendon repairs/reconstruction

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

Knee:

Medial collateral ligament repair

Lateral collateral ligament repair

Posterior oblique ligament repair

lliotibial band tenodesis

Patellar realignment and tendon repairs

Elbow:

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

Biceps tendon reattachment

Hip:

Gluteal tendon repairs

- Gluteus medius and gluteus minimus repair

Crius PEEK Suture Anchor System (Pile Anchor)

Shoulder:

Rotator Cuff Repair

Bankart Repair

SLAP Lesion Repair

Biceps Tenodesis

AcromioClavicular Separation Repair

Deltoid Repair

Capsular Shift or Capsulolabral Reconstruction

Foot/ Ankle:

Lateral Stabilization

Medial Stabilization

Achilles Tendon Repair

Metatarsal Ligament Repair/Tendon Repair

HALLUX Valgus Reconstruction

Mid-foot Reconstruction

Bunionectomy

Knee:

Medial Collateral Ligament Repair

Lateral Collateral Ligament Repair

Patellar Tendon Repair

Posterior Oblique Ligament Repair

lliotibial Band Tenodesis

Elbow:

Biceps Tendon Reattachment

Tennis Elbow Repair

Ulnar or Radial Collateral Ligament Reconstruction

Lateral Epicondylitis Repair

Hand/Wrist:

Scapholunate Ligament Reconstruction

Ulnar or Radial Collateral Ligament Reconstruction

Hip:

Acetabular Labral Repair

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K061665

13 other devices cite the same predicate.

  • K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
  • K181680ICONN Answer II Suture AnchorIconn Orthopedics, LLC · 2018
  • K180464AEVUMED PHANTOM Suture AnchorsAevumed, Inc. · 2018
  • K173788Arthrex Corkscrew FTArthrex, Inc. · 2018
  • K152236KATOR Suture AnchorKator, LLC · 2015
  • K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc. · 2012

More from ZheJiang Decans Medical Devices Co.…

11 FDA decisions under this applicant name. See the company

  • K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026

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/K243665 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243665: Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243665

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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