510(k) Report

510(k) · Cleared

Recalled · 2009

Stryker Peek and Titanium Soft Eyelet Anchors

K071157510(k) TraditionalCleared Sep 17, 2007145-day reviewClass II21 CFR 888.3040Recalls 5

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

Stryker Endoscopy · HWC Screw, Fixation, Bone

Cleared on Sep 17, 2007 as substantially equivalent to K061665 (Arthrex, Inc., 2006) after a 145-day review. Its family tree reaches back 3 generations to 2000. 12 later devices descend from it. It has been recalled 5 times.

Decided
Sep 17, 2007
Review
145 days
Class
Class II
Product code
HWC
Recalls
5
Predicates
1

Its longest line of descent runs back 3 generations to K990987 (2000). 4 ancestors in all. 12 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2015: 1 descendant cleared2008: 1 descendant cleared2024: 4 descendants cleared2018: 1 descendant cleared2023: 3 descendants cleared2026: 1 descendant cleared2025: 1 descendant clearedK990987 · Bio-Absorbable Corkscrew, Model AR-1920B · Arthrex, Inc. · 2000K043337 · Arthrex Bio-Corkscrew FT Suture Anchor · Arthrex, Inc. · 2004K061665 · Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT · Arthrex, Inc. · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K061665 · Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT · Arthrex, Inc. · 2006K043337 · Arthrex Bio-Corkscrew FT Suture Anchor · Arthrex, Inc. · 2004K990987 · Bio-Absorbable Corkscrew, Model AR-1920B · Arthrex, Inc. · 20000+5
  1. Root · 3 generations backK990987 Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc. · 2000
  2. 2 generations backK043337 Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc. · 2004
  3. 1 generation backK061665 Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc. · 2006
  4. This deviceK071157 Stryker Peek and Titanium Soft Eyelet AnchorsStryker Endoscopy · 2007
  5. Descendant · cites it directly · 10 of its ownK151201 Stryker ICONIX with NeedlesStryker · 2015
  6. Descendant · 2 generations on · 5 of its ownK173074 ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018
  7. Descendant · 3 generations on · 3 of its ownK231078 All-Suture AnchorRiverpoint Medical, LLC · 2023
  8. Descendant · 2 generations on · 3 of its ownK231278 Knotless Suture AnchorRiverpoint Medical, LLC · 2023 · Recalled
  9. Descendant · 4 generations on · 1 of its ownK233468 Iconix AnchorRiverpoint Medical · 2023

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2008: 12015: 12018: 12023: 32024: 42025: 12026: 1
2008high 4 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 12 · See all
  • K151201Stryker ICONIX with NeedlesStryker · 2015 · cites it directly10descendants
  • K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018 · 2 generations on5descendants
  • K231078All-Suture AnchorRiverpoint Medical, LLC · 2023 · 3 generations on3descendants
  • K231278Knotless Suture AnchorRiverpoint Medical, LLC · 2023 · 2 generations on3descendants
  • K233468Iconix AnchorRiverpoint Medical · 2023 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K990987Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc.2000—
−2K043337Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc.2004—
−1K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc.2006—
0 (this device)K071157Stryker Peek and Titanium Soft Eyelet AnchorsStryker Endoscopy2007—
+1K151201Stryker ICONIX with NeedlesStryker2015—
+2K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker2018—
+3K231078All-Suture AnchorRiverpoint Medical, LLC2023—
+2K231278Knotless Suture AnchorRiverpoint Medical, LLC20231
+4K233468Iconix AnchorRiverpoint Medical2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201510
201810
202330
202440
202510
202610
FIG. 1 — Lineage of K071157, 2000–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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
*K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT
Summary page 1
…(Class 11, 21 CFR 888.3040, Product Code MBI, Orthopedics Review Panel) Predicate Devices: Arthrex 5.5mm PEEK Corkscrew FT: #K061665 Device Description and Intended Use: The Stryker Intraline Anchors are soft tissue anchors which will be used for tissue fixatio…
Arthrex, Inc.2006—

Also cleared against K061665: 13 other devices →

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151201Stryker ICONIX with NeedlesStryker201510
K080447Surgicraft Screw Fixation SystemSurgicraft, Ltd.20080

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 20, 2009Not classifiedZ-0618-2011Material/Component ContaminationPotential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or immune response, or…
Feb 7, 2008Not classifiedZ-1536-2008PackagingProduct package may crack and cause loss of sterility.
Feb 7, 2008Not classifiedZ-1533-2008PackagingProduct package may crack and cause loss of sterility.
Feb 7, 2008Not classifiedZ-1535-2008PackagingProduct package may crack and cause loss of sterility.
Feb 7, 2008Not classifiedZ-1534-2008PackagingProduct package may crack and cause loss of sterility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K151201 (Stryker, 2015) has gone furthest, with 10 descendants of its own.
  • 13 other devices also cite its predicate K061665.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Stryker Intraline Anchor is a soft tissue anchor which will be used for tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. The anchor is intended for use in the following procedures: Shoulder: * Rotator Cuff Repair * Bankart Repair * SLAP Lesion Repair * Biceps Tenodesis * Acromio-Clavicular Separation Repair * Deltoid Repair * Capsular Shift/Capsulolabral Reconstruction. Foot and Ankle: * Lateral Stabilization…

Read the full statement (157 words)

The Stryker Intraline Anchor is a soft tissue anchor which will be used for tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. The anchor is intended for use in the following procedures:

Shoulder:

* Rotator Cuff Repair

* Bankart Repair

* SLAP Lesion Repair

* Biceps Tenodesis

* Acromio-Clavicular Separation Repair

* Deltoid Repair

* Capsular Shift/Capsulolabral Reconstruction.

Foot and 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

* Illiotibial Band Tenodesis

Hand and Wrist:

Scapholunate Ligament Reconstruction

Ulnar Collateral Ligament Reconstruction

Radial Collateral Ligament Reconstruction

Elbow:

Biceps Tendon Reattachment

* Ulnar or Radial Collateral Ligament Reconstruction

Pelvis:

Bladder Neck Suspension Procedures

The Stryker Soft Eyelet RC Anchor is intended for single-use only.

Indications for use as stated in the FDA summary.

Also cleared against K061665

13 other devices cite the same predicate.

  • K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra…ZheJiang Decans Medical Devices Co., Ltd. · 2025
  • 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

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https://510kreport.com/device/K071157 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071157: Stryker Peek and Titanium Soft Eyelet Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071157

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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