510(k) · Cleared
ClearedInFrame™ Cannulated Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exsomed Corp. · HWC Screw, Fixation, Bone
Cleared on Jun 20, 2020 as substantially equivalent to K171558 (Exsomed Holdings Company, LLC, 2017) and 2 other predicates after a 19-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.
- Decided
- Jun 20, 2020
- Review
- 19 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K962616 (1996). 111 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 2 generations backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- 1 generation backK161904 GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017
- This deviceK201430 InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020
- Descendant · cites it directly · 0 of its ownK220892 ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp. · 2022
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 3 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 2 generations backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- 1 generation backK161904 GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017
- This deviceK201430 InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020
Most influential descendants
Showing 1 of 1 · See all- K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −3 | K142442 | Magna-FX and Mini Magna-FX Cannulated Screw Fixation System | Zimmer, Inc. | 2014 | 3 |
| −2 | K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015 | — |
| −1 | K161904 | GEO Bone Screw System | Gramercy Extremity Orthopeidics, LLC | 2017 | — |
| 0 (this device) | K201430 | InFrame™ Cannulated Fixation System | Exsomed Corp. | 2020 | — |
| +1 | K220892 | ExsoMed INnate NanoTM Lag Screw System | Exsomed Corp. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 11 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 22.3 · 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 |
|---|---|---|---|
| * | K171558 | ExsoMed ITN Cannulated Screw SystemSummary page 5…ainless screws with a diameter of 2.0 mm and lengths ranging from 10 mm to 50 mm. Predicate Devices: ExsoMed ITN Cannulated Screw System (K171558) (Primary) INnate Cannulated Screw System (K183603) GEO Bone Screw System (K161… | 2017 |
| * | K183603 | INnate Cannulated Screw SystemSummary page 5…s ranging from 10 mm to 50 mm. Predicate Devices: ExsoMed ITN Cannulated Screw System (K171558) (Primary) INnate Cannulated Screw System (K183603) GEO Bone Screw System (K161904) Technology Comparison The ExsoMed InFrame™ Cannulated Fixation System… | 2019 |
| * | K161904 | GEO Bone Screw SystemSummary page 5…ExsoMed ITN Cannulated Screw System (K171558) (Primary) INnate Cannulated Screw System (K183603) GEO Bone Screw System (K161904) Technology Comparison The ExsoMed InFrame™ Cannulated Fixation System has and Non-Clinical differing specific geometry fr… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220892 | ExsoMed INnate NanoTM Lag Screw System | 2022 | 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 24 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 23 of the 111 ancestors have a recall of any class.
- Of its descendants, K220892 (Exsomed Corp., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K171558.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 ExsoMed InFrame™ Cannulated Fixation System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201430 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201430: InFrame™ Cannulated Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201430
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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