510(k) Report

510(k) · Cleared

Cleared

SFC

K951303510(k) TraditionalCleared Jun 27, 199597-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

Medpac · HWC Screw, Fixation, Bone

Cleared on Jun 27, 1995 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.

Decided
Jun 27, 1995
Review
97 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

28 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2013: 1 descendant cleared2017: 2 descendants cleared2022: 2 descendants cleared2004: 1 descendant cleared2001: 1 descendant cleared2025: 6 descendants cleared2018: 2 descendants cleared2020: 1 descendant cleared2026: 5 descendants cleared2024: 4 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951303 SFCMedpac · 1995
  2. Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  3. Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
  4. Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
  5. Descendant · cites it directly · 10 of its ownK010545 TBWTri-Med, Inc. · 2001
  6. Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12009: 12013: 12017: 22018: 22020: 12021: 12022: 22023: 12024: 42025: 62026: 5
2001high 6 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 28 · See all
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
  • K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
  • K010545TBWTri-Med, Inc. · 2001 · cites it directly10descendants
  • K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951303SFCMedpac1995—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.2017—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.2018—
+1K010545TBWTri-Med, Inc.2001—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200910
201310
201720
201820
202010
202110
202220
202310
202440
202560
202650
FIG. 1 — Lineage of K951303, 1995–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714
K010545TBWTri-Med, Inc.200110
K222637TriMed Wrist Fixation System 3TriMed, Inc.20223
K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130
K091156Trimed Sterile ProductTriMed, Inc.20090
K030877Trimed Radial BulletTri-Med, Inc.20040

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?

  • Of its descendants, K163361 (Globus Medical, Inc., 2017) has gone furthest, with 14 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Medpac

3 FDA decisions under this applicant name. See the company

  • K951302Small Fragment Plates and ScrewsMedpac · 19951 recall
  • K903697Hawaiian Supracondylar PlateMedpac · 1991

Recent decisions in HWC

The HWC category page

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  • 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/K951303 · printed Nov 5, 2026

Cite this page

510(k) Report. “K951303: SFC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951303

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026