510(k) Report

510(k) · Cleared

Cleared

PHIN-FX Cannulated Lag Screw System

K150693510(k) TraditionalCleared Oct 13, 2015209-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

Ascent Medical, LLC · HWC Screw, Fixation, Bone

Cleared on Oct 13, 2015 as substantially equivalent to K991197 (Vilex, Inc., 1999) and 13 other predicates after a 209-day review. Its family tree reaches back 11 generations to 1996. 9 later devices descend from it.

Decided
Oct 13, 2015
Review
209 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
14

Its longest line of descent runs back 11 generations to K962616 (1996). 104 ancestors in all, the oldest K792022 (1979). 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 1 other ancestor2010: 2 other ancestors2006: 6 other ancestors2002: 5 other ancestors2001: 8 other ancestors1999: 5 other ancestors1996: 11 other ancestors2011: 1 other ancestor2007: 2 other ancestors2005: 8 other ancestors1998: 4 other ancestors1995: 6 other ancestors2008: 2 other ancestors2004: 4 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 ancestor2017: 2 descendants cleared2020: 2 descendants cleared2023: 2 descendants cleared2022: 3 descendants 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 13 other ancestors2 generations back: 16 other ancestors3 generations back: 30 other ancestors4 generations back: 22 other ancestors5 generations back: 7 other ancestors6 generations back: 2 other ancestors7 generations back: 2 other ancestors8 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants K142442 · 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 · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 7 generations between
  3. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  4. 2 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  5. 1 generation backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
  6. This deviceK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
  7. Descendant · cites it directly · 4 of its ownK161904 GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017
  8. Descendant · cites it directly · 3 of its ownK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
  9. Descendant · 2 generations on · 1 of its ownK203773 BRM TOOL ScrewsBrm Extremities Srl · 2022
  10. Descendant · 2 generations on · 1 of its ownK202817 GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020
  11. Descendant · 2 generations on · 1 of its ownK201430 InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020
Show all 11 generations
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 2 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  11. 1 generation backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
  12. This deviceK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2017: 22020: 22022: 32023: 2
2017high 3 (2022) · low 0 (2018)2026

Most influential descendants

Showing 5 of 9 · See all
  • K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017 · cites it directly4descendants
  • K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · cites it directly3descendants
  • K203773BRM TOOL ScrewsBrm Extremities Srl · 2022 · 2 generations on1descendant
  • K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020 · 2 generations on1descendant
  • K201430InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−10K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−9K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−8K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−5K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−4K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—
−1K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.20143
0 (this device)K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC2015—
+1K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC2017—
+1K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited20171
+2K203773BRM TOOL ScrewsBrm Extremities Srl2022—
+2K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC2020—
+2K201430InFrame™ Cannulated Fixation SystemExsomed Corp.2020—

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
200440
200580
200660
200720
200820
201020
201110
201210
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
202020
202230
202320
FIG. 1 — Lineage of K150693, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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What was it cleared against? (14)

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
*K991197Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…
Summary page 4
…, Class II (21CRF, Sec. 888.3030) DEVICE PRODUCT CODE: HWC SUBSEQUENT PRODUCT CODE: HTN SUBSTANTIALLY Vilex – Cannulated Bone Screws (K991197, K014154) EQUIVALENT DEVICE Synthes – Cannulated Screws & Washers (K012945, K962823, K963192, K96…
Vilex, Inc.1999—
*K014154Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…
Summary page 4
…I (21CRF, Sec. 888.3030) DEVICE PRODUCT CODE: HWC SUBSEQUENT PRODUCT CODE: HTN SUBSTANTIALLY Vilex – Cannulated Bone Screws (K991197, K014154) EQUIVALENT DEVICE Synthes – Cannulated Screws & Washers (K012945, K962823, K963192, K963172, K02…
Vilex, Inc.2002—
*K012945Synthes 2.4 MM Cannulated Screw
Summary page 4
…ODUCT CODE: HTN SUBSTANTIALLY Vilex – Cannulated Bone Screws (K991197, K014154) EQUIVALENT DEVICE Synthes – Cannulated Screws & Washers (K012945, K962823, K963192, K963172, K021932 & K962011) Zimmer/Pioneer – Cannulated Scre…
Synthes (Usa)20011
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 4
…E: HTN SUBSTANTIALLY Vilex – Cannulated Bone Screws (K991197, K014154) EQUIVALENT DEVICE Synthes – Cannulated Screws & Washers (K012945, K962823, K963192, K963172, K021932 & K962011) Zimmer/Pioneer – Cannulated Screw & Washe…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 4
…Y Vilex – Cannulated Bone Screws (K991197, K014154) EQUIVALENT DEVICE Synthes – Cannulated Screws & Washers (K012945, K962823, K963192, K963172, K021932 & K962011) Zimmer/Pioneer – Cannulated Screw & Washer System (K102903,…
Synthes (Usa)1996—
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 4
…Vilex – Cannulated Bone Screws (K991197, K014154) EQUIVALENT DEVICE Synthes – Cannulated Screws & Washers (K012945, K962823, K963192, K963172, K021932 & K962011) Zimmer/Pioneer – Cannulated Screw & Washer System (K102903,…
Synthes (Usa)1996—
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 4
…– Cannulated Bone Screws (K991197, K014154) EQUIVALENT DEVICE Synthes – Cannulated Screws & Washers (K012945, K962823, K963192, K963172, K021932 & K962011) Zimmer/Pioneer – Cannulated Screw & Washer System (K102903, K003496…
Synthes (Usa)20027
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 4
…ted Bone Screws (K991197, K014154) EQUIVALENT DEVICE Synthes – Cannulated Screws & Washers (K012945, K962823, K963192, K963172, K021932 & K962011) Zimmer/Pioneer – Cannulated Screw & Washer System (K102903, K003496 & K142442)…
Synthes (Usa)1996—
*K102903Pioneer Cannulated Screw System
Summary page 4
…ws & Washers (K012945, K962823, K963192, K963172, K021932 & K962011) Zimmer/Pioneer – Cannulated Screw & Washer System (K102903, K003496 & K142442) Instratek – Mini Cannulated Screws (K120493)…
Pioneer Surgical Technology, Inc.2010—
*K003496Cannulated Screw System
Summary page 4
…K963192, K963172, K021932 & K962011) Zimmer/Pioneer – Cannulated Screw & Washer System (K102903, K003496 & K142442) Instratek – Mini Cannulated Screws (K120493) Acumed - Cannulated Scr…
Pioneer Surgical Technology20011
*K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation System
Summary page 4
…K963192, K963172, K021932 & K962011) Zimmer/Pioneer – Cannulated Screw & Washer System (K102903, K003496 & K142442) Instratek – Mini Cannulated Screws (K120493) Acumed - Cannulated Screw System…
Zimmer, Inc.20143
*K120493Mini Cannulated Headed and Headless Screw Set
Summary page 4
…Zimmer/Pioneer – Cannulated Screw & Washer System (K102903, K003496 & K142442) Instratek – Mini Cannulated Screws (K120493) Acumed - Cannulated Screw System (K123890) I.T.S. GmbH – Cannulated Screws (K0…
Instratek, Inc.20121
*K123890Acumed Cannulated Screw System
Summary page 4
…K003496 & K142442) Instratek – Mini Cannulated Screws (K120493) Acumed - Cannulated Screw System (K123890) I.T.S. GmbH – Cannulated Screws (K060156) Page 1 o…
Acumed, LLC20132
*K060156Straight Plate with Angular Stability & Screw System
Summary page 4
…nstratek – Mini Cannulated Screws (K120493) Acumed - Cannulated Screw System (K123890) I.T.S. GmbH – Cannulated Screws (K060156) Page 1 of 3 Section XII…
I.T.S. Implantat-Technologie-Systeme GmbH20062

Also cleared against K991197: 13 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174
K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited20173

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 19 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
  • 23 of the 104 ancestors have a recall of any class.
  • Of its descendants, K161904 (Gramercy Extremity Orthopeidics, LLC, 2017) has gone furthest, with 4 descendants of its own.
  • 13 other devices also cite its predicate K991197.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 intended use of the Ascent Medical – PHIN-FX Cannulated Lag Screw System is to draw two or more aligned bone fragments together in an adult patient. The Ascent Medical – PHIN-FX Cannulated Lag Screw System is indicated for use for small and long bone fractures, arthrodesis and osteotomy fixation as follows: The Mini and Small - PHIN-FX Cannulated Lag Screw Systems are indicated for small bone fractures and reduction of the glenoid and humeral head…

Read the full statement (216 words)

The intended use of the Ascent Medical – PHIN-FX Cannulated Lag Screw System is to draw two or more aligned bone fragments together in an adult patient.

The Ascent Medical – PHIN-FX Cannulated Lag Screw System is indicated for use for small and long bone fractures, arthrodesis and osteotomy fixation as follows:

The Mini and Small - PHIN-FX Cannulated Lag Screw Systems are indicated for small bone fractures and reduction of the glenoid and humeral head, medial malleolus and fibula, distal tibia and pilon, radius and ulna, olecranon and distal humerus, patella, pelvis, tarsal and fusions, metatarsal and phalangeal and with osteotomies, small bones in the hand and wrist, ligament fixation when appropriate, small joint fusion, and other small bone fragment cancellous fractures and osteotomies where the size of the screw/washer adapts to the specific indication.

The Large – PHIN-FX Cannulated Lag Screw System is indicated for long bone fractures and reduction of the intracapsular hip, slipped capital femoral epiphysis with proper image fluoroscopy for proper screw placement, femoral condyles, tibia condyles, ankle arthrodesis, large bone calcaneus and talus, acetabulum, sacroiliac and pelvic disruptions, and other areas where accurate screw/washer placement in long bone is required and adapts to the specific indication.

The Ascent Medical – PHIN-FX Cannulated Lag Screw System is not for spinal use.

Indications for use as stated in the FDA summary.

Also cleared against K991197

13 other devices cite the same predicate.

  • K250304TITANEX Screw SystemsVilex, LLC · 2025
  • K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLC · 2023
  • K191289Bone Screw Line AdditionVilex IN Tennessee, Inc. · 2019
  • K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 2018
  • K171690Trident Extremity Fixation SystemTrident Orthopedics · 2018
  • K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 20171 recall

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
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https://510kreport.com/device/K150693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150693: PHIN-FX Cannulated Lag 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/K150693

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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