510(k) Report

510(k) · Cleared

Cleared

GEO Bone Screw System

K161904510(k) TraditionalCleared Jan 18, 2017191-day reviewClass II21 CFR 888.3040

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

Gramercy Extremity Orthopeidics, LLC · HWC Screw, Fixation, Bone

Cleared on Jan 18, 2017 as substantially equivalent to K991151 (Vilex, Inc., 1999) and 4 other predicates after a 191-day review. Its family tree reaches back 12 generations to 1996. 4 later devices descend from it.

Decided
Jan 18, 2017
Review
191 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 12 generations to K962616 (1996). 108 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2004: 5 other ancestors1999: 5 other ancestors2013: 1 other ancestor2012: 1 other ancestor2010: 2 other ancestors2008: 3 other ancestors2006: 6 other ancestors2002: 5 other ancestors2001: 8 other ancestors1996: 11 other ancestors2011: 1 other ancestor2007: 2 other ancestors2005: 8 other ancestors1998: 4 other ancestors1995: 6 other ancestors2003: 2 other ancestors2000: 8 other ancestors1994: 4 other ancestors1993: 2 other ancestors1992: 3 other ancestors1991: 1 other ancestor1990: 1 other ancestor1989: 3 other ancestors1979: 2 other ancestors1981: 1 other ancestor2020: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K111994 · Smith & Nephew Cannulated Screws and Washers · Smith & Nephew, Inc. · 2011K142442 · Magna-FX and Mini Magna-FX Cannulated Screw Fixation System · Zimmer, Inc. · 2014 · recalledK150693 · PHIN-FX Cannulated Lag Screw System · Ascent Medical, LLC · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 13 other ancestors3 generations back: 15 other ancestors4 generations back: 30 other ancestors5 generations back: 22 other ancestors6 generations back: 7 other ancestors7 generations back: 2 other ancestors8 generations back: 2 other ancestors9 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants K150693 · PHIN-FX Cannulated Lag Screw System · Ascent Medical, LLC · 2015K142442 · Magna-FX and Mini Magna-FX Cannulated Screw Fixation System · Zimmer, Inc. · 2014 · recalledK111994 · Smith & Nephew Cannulated Screws and Washers · Smith & Nephew, Inc. · 2011K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations between
  3. 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  4. 2 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
  5. 1 generation backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
  6. This deviceK161904 GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017
  7. Descendant · cites it directly · 1 of its ownK202817 GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020
  8. Descendant · cites it directly · 1 of its ownK201430 InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020
  9. Descendant · 2 generations on · 0 of its ownK230946 Accelerate Compression Screw System-Small Product Code ACC-S…Trax Surgical · 2023
  10. Descendant · 2 generations on · 0 of its ownK220892 ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp. · 2022
Show all 12 generations
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  11. 2 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
  12. 1 generation backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
  13. This deviceK161904 GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017

Most influential descendants

Showing 4 of 4 · See all
  • K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020 · cites it directly1descendant
  • K201430InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020 · cites it directly1descendant
  • K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical · 2023 · 2 generations on0descendants
  • K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−11K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−10K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−9K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−5K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−4K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—
−2K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.20143
−1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC2015—
0 (this device)K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC2017—
+1K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC2020—
+1K201430InFrame™ Cannulated Fixation SystemExsomed Corp.2020—
+2K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate…Trax Surgical2023—
+2K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197920
198110
198930
199010
199110
199230
199320
199440
199560
1996110
199840
199950
200080
200180
200250
200320
200450
200580
200660
200720
200830
201020
201110
201210
201310
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202210
202310
FIG. 1 — Lineage of K161904, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K991151Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw
Summary page 4
…§ 888.3040 – Class II 21 CFR § 888.3030 – Class II Product Codes: HWC HTN Primary Predicate K991151/K991197: Cannulated Screws (Vilex) Additional Predicates K042310: Cannulated Bone Screws (OrthoPro)…
Vilex, Inc.1999—
*K991197Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…
Summary page 4
…040 – Class II 21 CFR § 888.3030 – Class II Product Codes: HWC HTN Primary Predicate K991151/K991197: Cannulated Screws (Vilex) Additional Predicates K042310: Cannulated Bone Screws (OrthoPro) K143460…
Vilex, Inc.1999—
*K042310Ortho-Pro Cannulated Bone Screws
Summary page 4
…Codes: HWC HTN Primary Predicate K991151/K991197: Cannulated Screws (Vilex) Additional Predicates K042310: Cannulated Bone Screws (OrthoPro) K143460: Cannulated Screw System (Wright Medical)…
Ortho-Pro, LLC2004—
*K143460Cannulated Screw System
Summary page 4
…HTN Primary Predicate K991151/K991197: Cannulated Screws (Vilex) Additional Predicates K042310: Cannulated Bone Screws (OrthoPro) K143460: Cannulated Screw System (Wright Medical) K150693: PHIN-FX Cannulated Lag Screw System (Ascent…
Wrightmedicaltechnologyinc2015—
*K150693PHIN-FX Cannulated Lag Screw System
Summary page 4
…dditional Predicates K042310: Cannulated Bone Screws (OrthoPro) K143460: Cannulated Screw System (Wright Medical) K150693: PHIN-FX Cannulated Lag Screw System (Ascent Medical, LLC.) Device Description: The GEO Bone Scre…
Ascent Medical, LLC2015—

Also cleared against K991151: 9 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201
K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201

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 21 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
  • 23 of the 108 ancestors have a recall of any class.
  • Of its descendants, K202817 (Gramercy Extremity Orthopedics, LLC, 2020) has gone furthest, with 1 descendant of its own.
  • 9 other devices also cite its predicate K991151.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K991151

9 other devices cite the same predicate.

  • K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 2018
  • K171690Trident Extremity Fixation SystemTrident Orthopedics · 2018
  • K124027Monster Screw SystemApogee Orthosolutions · 2013
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 20121 recall
  • K092440Ascension Cannulated Screw SystemAscension Orthopedics, Inc. · 2009
  • K091798Merete Compression ScrewsMerete Medical GmbH · 2009

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K161904 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161904: GEO Bone Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161904

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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