510(k) · Cleared
ClearedCoLink® & CoLag® Non-Sterile Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2Bones USA, LLC · HWC Screw, Fixation, Bone
Cleared on May 30, 2026 as substantially equivalent to K181113 (In2bones USA, LLC, 2018) and 2 other predicates after a 52-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- May 30, 2026
- Review
- 52 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K962616 (1996). 226 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- 2 generations backK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- 1 generation backK210060 CoLink Mfx Implant SystemIn2bones USA, LLC · 2021
- This deviceK261154 CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC · 2026
Show all 17 generations
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 16 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 15 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 14 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 13 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 12 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 11 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 10 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 9 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 8 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 7 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 6 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 5 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 4 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 3 generations backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- 2 generations backK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- 1 generation backK210060 CoLink Mfx Implant SystemIn2bones USA, LLC · 2021
- This deviceK261154 CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −16 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −15 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −14 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −13 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −12 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −11 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −10 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −9 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −8 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −7 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −6 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −5 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −4 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| −3 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| −2 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
| −1 | K210060 | CoLink Mfx Implant System | In2bones USA, LLC | 2021 | — |
| 0 (this device) | K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 10 | 0 |
| 2000 | 13 | 0 |
| 2001 | 17 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 14 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 10 | 0 |
| 2009 | 8 | 0 |
| 2010 | 10 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 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? (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 |
|---|---|---|---|
| * | K181113 | CoLink™ Afx Plating SystemSummary page 6…21 CFR 888.3040 III. PREDICATE/LEGALLY MARKETED DEVICE Primary Device Name: CoLink® Afx Company Name: In2Bones USA 510(k): K181113 Additional Predicate Device Name: CoLink® Mfx Company Name: In2Bones USA 510(k): K210060… | 2018 |
| * | K210060 | CoLink Mfx Implant SystemSummary page 6…Company Name: In2Bones USA 510(k): K181113 Additional Predicate Device Name: CoLink® Mfx Company Name: In2Bones USA 510(k): K210060 Additional Predicate Device Name: CoLag®2 Company Name: In2Bones USA 510(k): K180377 IV. D… | 2021 |
| * | K180377 | Fracture and Correction SystemSummary page 6…Company Name: In2Bones USA 510(k): K210060 Additional Predicate Device Name: CoLag®2 Company Name: In2Bones USA 510(k): K180377 IV. DEVICE DESCRIPTION The subject CoLink and CoLag Non-Sterile screws are titanium alloy (Ti6Al4V ELI) screws int… | 2018 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 45 of the 226 ancestors have a recall of any class.
- 8 other devices also cite its predicate K181113.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 In2Bones USA CoLink Non-Sterile screws when used in conjunction with compatible plating systems are indicated for: CoLink T8 2.7mm Screws: When used with the CoLink Afx Plating System: Stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula in both pediatric and adult patients. CoLink T15 3.0mm Screws: When used with the CoLink Mfx System: Stabilization and fixation of fractures, revision procedures, joint…
Read the full statement (305 words)
The In2Bones USA CoLink Non-Sterile screws when used in conjunction with compatible plating systems are indicated for:
CoLink T8 2.7mm Screws:
When used with the CoLink Afx Plating System: Stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula in both pediatric and adult patients.
CoLink T15 3.0mm Screws:
When used with the CoLink Mfx System: Stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries.
ColLink T15 3.5mm Screws:
When used with the CoLink Afx Plating System: Stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula in both pediatric and adult patients in both pediatric and adult patients.
When used with the CoLink Mfx Plating System: Stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries in both pediatric and adult patients.
The In2Bones USA Colag Non-sterile screws, when used in conjunction with compatible plating systems or used independently in a lag screw technique are indicated for:
Colag T8 3.0mm Screws:
When used with the Colag Fracture and Correction System: Internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
ColLag T15 4.0mm Screws:
When used with the Colag Fracture and Correction System: Internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
When used with the CoLink® Mfx System: Stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries in both pediatric and adult patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261154: CoLink® & CoLag® Non-Sterile Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261154
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026