510(k) · Cleared
Recalled · 2009Peek Knotless Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Sports Medicine, Inc. · HWC Screw, Fixation, Bone
Cleared on Aug 9, 2007 as substantially equivalent to K060693 (Arthrotek, Inc., 2006) and 2 other predicates after a 181-day review. Its family tree reaches back 3 generations to 1995. 9 later devices descend from it. It has been recalled once.
- Decided
- Aug 9, 2007
- Review
- 181 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K943806 (1995). 12 ancestors in all, the oldest K931519 (1994). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
- 2 generations backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
- 1 generation backK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
- This deviceK070389 Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK110230 Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK111590 Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK113299 Rog Suture AnchorRog Sports Medicine, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK112991 Modified Rog Suture AnchorRog Sports Medicine, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK230517 Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm…Jarmon Medical, LLC (Dba Legends Orthopedics) · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K110230Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011 · cites it directly7descendants
- K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011 · 2 generations on5descendants
- K113299Rog Suture AnchorRog Sports Medicine, Inc. · 2011 · 3 generations on2descendants
- K112991Modified Rog Suture AnchorRog Sports Medicine, Inc. · 2011 · 3 generations on1descendant
- K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics) · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943806 | Harpoon Suture Anchors | Biomet, Inc. | 1995 | — |
| −2 | K012872 | Resorbable Screw Anchor | Arthrotek, Inc. | 2001 | — |
| −1 | K041274 | Resorbable Interference Screw | Arthrotek, Inc. | 2004 | 5 |
| 0 (this device) | K070389 | Peek Knotless Anchors | Biomet Sports Medicine, Inc. | 2007 | — |
| +1 | K110230 | Rog Knotless Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| +2 | K111590 | Rog Suture Anchor, Rog Knotless Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| +3 | K113299 | Rog Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| +3 | K112991 | Modified Rog Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| +3 | K230517 | Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors… | Jarmon Medical, LLC (Dba Legends Orthopedics) | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 4 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 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 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K060693 | Microstrike and Allthread Peek Suture AnchorSummary page 1…CFR §888.3040), HWC Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * ALLthread TM PEEK Suture Anchors K060693 Arthrotek, Inc. * Resorbable Interference Screw K<041274 Arthrotek, Inc. * Soft Tissue Screw and Washer… | 2006 |
| * | K041274 | Resorbable Interference ScrewSummary page 1…Devices To Which Substantial Equivalence Is Claimed: * ALLthread TM PEEK Suture Anchors K060693 Arthrotek, Inc. * Resorbable Interference Screw K<041274 Arthrotek, Inc. * Soft Tissue Screw and Washer K<012572 Arthrotek, Inc. Device Description: The PEEK Knotless Ancho… | 2004 |
| * | K012572 | Soft Tissue Screw and WasherSummary page 1…PEEK Suture Anchors K060693 Arthrotek, Inc. * Resorbable Interference Screw K<041274 Arthrotek, Inc. * Soft Tissue Screw and Washer K<012572 Arthrotek, Inc. Device Description: The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised o… | 2001 |
What descends from it? (9)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2009 | Not classified | Z-0191-2010 | Device Design | These anchors may be difficult to remove, or may not detach from the inserter shaft. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K110230 (Rog Sports Medicine, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K060693.
How does its category compare?
All HWC devicesHWC 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
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament…
Read the full statement (127 words)
Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair
Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction
Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction
Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair
Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement
The PEEK Knotless Anchors are single-use devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070389: Peek Knotless Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070389
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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