510(k) Report

510(k) · Cleared

Cleared

Orthopedic Screw System

K972217510(k) TraditionalCleared Nov 20, 1997161-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

Ferguson Medical · HWC Screw, Fixation, Bone

Cleared on Nov 20, 1997 as substantially equivalent to K792022 (Zimmer, Inc., 1979) and 8 other predicates after a 161-day review. Its family tree reaches back 2 generations to 1979.

Decided
Nov 20, 1997
Review
161 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
9

Its longest line of descent runs back 2 generations to K792022 (1979). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 2 other ancestors1994: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor1979: 1 other ancestor1990: 1 other ancestorK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalledK960537 · K2 Bone Screw System · Kinetikos Medical, Inc. · 199619751980198519901995
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 1 other ancestor K960537 · K2 Bone Screw System · Kinetikos Medical, Inc. · 1996K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled0
  1. Root · 2 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. 1 generation backK960537 K2 Bone Screw SystemKinetikos Medical, Inc. · 1996
  3. This deviceK972217 Orthopedic Screw SystemFerguson Medical · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K792022Herbert Bone ScrewZimmer, Inc.19796
−1K960537K2 Bone Screw SystemKinetikos Medical, Inc.1996—
0 (this device)K972217Orthopedic Screw SystemFerguson Medical1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199010
199210
199310
199420
199620
FIG. 1 — Lineage of K972217, 1979–1997Source: 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? (9)

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
*K792022Herbert Bone Screw
Summary page 1
…ame: Screw, fixation, bone Common/usual name: Screw, bone screw, etc. Proprietary name: Orthopedic Screw System B. Substantial equivalence: Zimmer, Herbert Bone Screw (K792022), Synthes, Synthes Reconstructive Plates "Y" Plates (K792291), Alphatec Manufacturing, Inc., Alphatec Compression Hip Screw Syste…
Zimmer, Inc.19796
*K792291Synthes Reconstructive Plates 'Y' Plates
Summary page 1
…ew, etc. Proprietary name: Orthopedic Screw System B. Substantial equivalence: Zimmer, Herbert Bone Screw (K792022), Synthes, Synthes Reconstructive Plates "Y" Plates (K792291), Alphatec Manufacturing, Inc., Alphatec Compression Hip Screw System (K921622), Osteomed, M3 Lag Screw Fixation System (K924018)…
Synthes (Usa)1979—
*K921622Alphatec Compression Hip Screw System
Summary page 1
…: Zimmer, Herbert Bone Screw (K792022), Synthes, Synthes Reconstructive Plates "Y" Plates (K792291), Alphatec Manufacturing, Inc., Alphatec Compression Hip Screw System (K921622), Osteomed, M3 Lag Screw Fixation System (K924018), Howmedica, Fully Threaded Alta Cancellous Bone Screw (K931524), Aesculap, Tit…
Alphatec Mfg., Inc.1992—
*K924018M3 Lag Screw Fixation System
Summary page 1
…ynthes Reconstructive Plates "Y" Plates (K792291), Alphatec Manufacturing, Inc., Alphatec Compression Hip Screw System (K921622), Osteomed, M3 Lag Screw Fixation System (K924018), Howmedica, Fully Threaded Alta Cancellous Bone Screw (K931524), Aesculap, Titanium Alloy Bone Screws (K940207), Kinetikos Medic…
Osteomed Corp.1993—
*K931524Fully Threaded Alta Cancellous Bone Screw
Summary page 1
…facturing, Inc., Alphatec Compression Hip Screw System (K921622), Osteomed, M3 Lag Screw Fixation System (K924018), Howmedica, Fully Threaded Alta Cancellous Bone Screw (K931524), Aesculap, Titanium Alloy Bone Screws (K940207), Kinetikos Medical, Inc., K2 Bone Screw System (K960537), DePuy, Inc, DePuy Adva…
Howmedica Corp.1994—
*K940207Titanium Alloy Bone Screws
Summary page 1
…System (K921622), Osteomed, M3 Lag Screw Fixation System (K924018), Howmedica, Fully Threaded Alta Cancellous Bone Screw (K931524), Aesculap, Titanium Alloy Bone Screws (K940207), Kinetikos Medical, Inc., K2 Bone Screw System (K960537), DePuy, Inc, DePuy Advantage Fixation Screw System (K961234), Synthes,…
Aesculap, Inc.1994—
*K960537K2 Bone Screw System
Summary page 1
…(K924018), Howmedica, Fully Threaded Alta Cancellous Bone Screw (K931524), Aesculap, Titanium Alloy Bone Screws (K940207), Kinetikos Medical, Inc., K2 Bone Screw System (K960537), DePuy, Inc, DePuy Advantage Fixation Screw System (K961234), Synthes, Synthes Sterile 7.0/7.3 mm Cannulated Screws (K962011).…
Kinetikos Medical, Inc.1996—
*K961234Depuy Advantage Fixation Screw System
Summary page 1
…ew (K931524), Aesculap, Titanium Alloy Bone Screws (K940207), Kinetikos Medical, Inc., K2 Bone Screw System (K960537), DePuy, Inc, DePuy Advantage Fixation Screw System (K961234), Synthes, Synthes Sterile 7.0/7.3 mm Cannulated Screws (K962011). C. Device Description: The device is an assortment of various…
Depuy, Inc.1996—
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 1
…etikos Medical, Inc., K2 Bone Screw System (K960537), DePuy, Inc, DePuy Advantage Fixation Screw System (K961234), Synthes, Synthes Sterile 7.0/7.3 mm Cannulated Screws (K962011). C. Device Description: The device is an assortment of various sizes and configurations of stainless steel bone screws. D. Int…
Synthes (Usa)1996—

Also cleared against K792022: 17 other devices →

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 18 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • 17 other devices also cite its predicate K792022.

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—

What is it indicated for?

The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

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 K792022

17 other devices cite the same predicate.

  • K083144Acumed Clavicle Screw SystemAcumed, LLC · 2009
  • K081011Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45Arex USA · 2008
  • K063298Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
  • K063244Arc Surgical Bone Reduction ScrewArc Surgical, LLC · 2006
  • K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
  • K050924Merete Duothreadtm Bone ScrewMerete Medical GmbH · 2005

More from Ferguson Medical

57 FDA decisions under this applicant name. See the company

  • K033153Dicom TheaterFerguson Medical · 2004
  • K962615Tumorlocalizer MriFerguson Medical · 1998
  • K963794PunctureneedleFerguson Medical · 1998
  • K971813EMBLAFerguson Medical · 1998
  • K972219Orthopedic Plate SystemFerguson Medical · 1997

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/K972217 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972217: Orthopedic Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972217

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