510(k) · Cleared
ClearedGryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · HWC Screw, Fixation, Bone
Cleared on Mar 11, 2011 as substantially equivalent to K100012 (Depuy Mitek, A Johnson & Johnson Company, 2010) and 4 other predicates after an 81-day review. Its family tree reaches back 10 generations to 1997. 6 later devices descend from it.
- Decided
- Mar 11, 2011
- Review
- 81 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K971358 (1997). 54 ancestors in all, the oldest K930893 (1993). 6 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 6 generations between
- 3 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 2 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 1 generation backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · cites it directly · 1 of its ownK141259 Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with…Depuy Mitek, A Johnson & Johnson Company · 2014
- Descendant · cites it directly · 1 of its ownK132241 Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/…Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · 2 generations on · 0 of its ownK181809 GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL · 2018
- Descendant · cites it directly · 0 of its ownK140643 Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/…Depuy Mitek, A Johnson and Johnson Company · 2014
- Descendant · cites it directly · 0 of its ownK130105 Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl…Depuy Mitek, A Johnson & Johnson Company · 2013
Show all 10 generations
- Root · 10 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 9 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 8 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 7 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 6 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 5 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 4 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 3 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 2 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 1 generation backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company · 2014 · cites it directly1descendant
- K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company · 2013 · cites it directly1descendant
- K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL · 2018 · 2 generations on0descendants
- K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company · 2014 · cites it directly0descendants
- K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −9 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −8 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −7 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −6 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −5 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −4 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −3 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
| −2 | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| −1 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| 0 (this device) | K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +1 | K141259 | Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2014 | — |
| +1 | K132241 | Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot… | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +2 | K181809 | GRYPHON® Anchors with DYNACORD™ Suture | Medos International SARL | 2018 | — |
| +1 | K140643 | Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot Technology | Depuy Mitek, A Johnson and Johnson Company | 2014 | — |
| +1 | K130105 | Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross… | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Summary page 1…ary Name: Gryphon PEEK Anchor Substantial Equivalence Gryphon PEEK Anchors are Substantially equivalent to: *K100012 Gryphon BR Anchor -Hip (April 30, 2010) * K090 124 Gryphon P BR Anchor (March 11, 2009)… | 2010 |
| * | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Summary page 1…are Substantially equivalent to: *K100012 Gryphon BR Anchor -Hip (April 30, 2010) * K090 124 Gryphon P BR Anchor (March 11, 2009); * K07 1481 Healix Peek Anchor (AuguIst 9. 2007)… | 2009 |
| * | K071481 | Healix AnchorSummary page 1…on BR Anchor -Hip (April 30, 2010) * K090 124 Gryphon P BR Anchor (March 11, 2009); * K07 1481 Healix Peek Anchor (AuguIst 9. 2007) " K 102298 TransTend Anchor (January 7, 2011)… | 2007 |
| * | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor… Cleared while this submission was under review Summary page 1…yphon P BR Anchor (March 11, 2009); * K07 1481 Healix Peek Anchor (AuguIst 9. 2007) " K 102298 TransTend Anchor (January 7, 2011) *K073412 Gryphon BR and Healix BR Anchor (January 17… | 2011 |
| * | K073412 | Gryphon BR and Healix BR AnchorsSummary page 1…1 Healix Peek Anchor (AuguIst 9. 2007) " K 102298 TransTend Anchor (January 7, 2011) *K073412 Gryphon BR and Healix BR Anchor (January 17, 2008) Device Classification… | 2008 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141259 | Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek… | 2014 | 1 |
| K132241 | Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip… | 2013 | 1 |
| K140643 | Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot Technology | 2014 | 0 |
| K130105 | Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin System | 2013 | 0 |
| K113534 | Healix Knotless Anchor | 2011 | 0 |
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 14 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 13 of the 54 ancestors have a recall of any class.
- Of its descendants, K141259 (Depuy Mitek, A Johnson & Johnson Company, 2014) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K100012.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The GRYPHON PEEK Anchor is intended for:
Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acrondo-Clavicular Separation Repair. Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular repair, acetabular labral repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103712: Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103712
Report an extraction error
Are you the manufacturer?
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