510(k) Report

510(k) · Cleared

Cleared

Ultimate Compression Screw System

K972722510(k) TraditionalCleared Jan 23, 1998186-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

Orthopedic Designs, Inc. · HWC Screw, Fixation, Bone

Cleared on Jan 23, 1998 as substantially equivalent to K944330 (Acu Med, Inc., 1995) and 2 other predicates after a 186-day review. Its family tree reaches back 1 generation to 1979.

Decided
Jan 23, 1998
Review
186 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K792022 (1979). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1993: 1 other ancestorK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled197519801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled0
  1. Root · 1 generation backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. This deviceK972722 Ultimate Compression Screw SystemOrthopedic Designs, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792022Herbert Bone ScrewZimmer, Inc.19796
0 (this device)K972722Ultimate Compression Screw SystemOrthopedic Designs, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
FIG. 1 — Lineage of K972722, 1979–1998Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K944330Acutrak Plus Fixation System
Summary page 4
…Il products is approved and commercially available with indications for use comparable to the ODi Ultimate Compression Screw™. 1) Acutrak Fixation System Acutek, Inc. K944330 2) Herbert/Whipple Bone Screw Zimmer, Inc. K792022 3) Universal Compression Screw Howmedica, Inc. K923477 33…
Acu Med, Inc.1995—
*K792022Herbert Bone Screw
Summary page 4
…with indications for use comparable to the ODi Ultimate Compression Screw™. 1) Acutrak Fixation System Acutek, Inc. K944330 2) Herbert/Whipple Bone Screw Zimmer, Inc. K792022 3) Universal Compression Screw Howmedica, Inc. K923477 33 - RVICE, N SE s W &, W R C DEPARTMENT OF HEALTH &…
Zimmer, Inc.19796
*K9234773.5MM Universal Compression Screw
Summary page 4
…Compression Screw™. 1) Acutrak Fixation System Acutek, Inc. K944330 2) Herbert/Whipple Bone Screw Zimmer, Inc. K792022 3) Universal Compression Screw Howmedica, Inc. K923477 33 - RVICE, N SE s W &, W R C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service § MEALTY o s, g o…
Howmedica Corp.1993—

Also cleared against K944330: 7 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?

  • 1 of the 3 ancestors has a recall of any class.
  • 7 other devices also cite its predicate K944330.

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 ODi Ultimate Compression Screw System™ was designed for use on indications comparable to those for approved and marketed devices. The primary indications are for the stabilization of osteotomies in small bones, and the fixation of unstable or interfragmentary fractures. This device is not intended for use in the spine. The ODi Ultimate Compression Screw™ is indicated for: Small Hand Bone Fractures Carpal and Metacarpal Fractures Tarsal and Metatarsal…

Read the full statement (113 words)

The ODi Ultimate Compression Screw System™ was designed for use on indications comparable to those for approved and marketed devices. The primary indications are for the stabilization of osteotomies in small bones, and the fixation of unstable or interfragmentary fractures. This device is not intended for use in the spine. The ODi Ultimate Compression Screw™ is indicated for:

Small Hand Bone Fractures

Carpal and Metacarpal Fractures

Tarsal and Metatarsal Fractures

Distal Metatarsal Osteotomies (Austin Chevron, Scarf)

Interfragmentary Radius and Ulna Fractures

Osteochondral Fractures

Intra-articular fractures

Arthrodesis of small joints

Reconstructive osteotomies in small carpal or tarsal bones

Osteochondritis Dissecans

Oblique fractures of the fibula

Metatarsal osteotomies and other reconstructive surgeries in the foot

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 K944330

7 other devices cite the same predicate.

  • K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd. · 2023
  • K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC · 20224 recalls
  • K170038FuzeFix Screw SystemFusion Orthopedics, LLC · 2017
  • K170594I.B.S. osteosynthesis screwsIn2bones Sas · 2017
  • K131920Stabilization ScrewIn2bones Sas · 20143 recalls
  • K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 20052 recalls

More from Orthopedic Designs, Inc.

4 FDA decisions under this applicant name. See the company

  • K030619Odi 7.0MM Cannulated Screw SystemOrthopedic Designs, Inc. · 2003
  • K014189Odi Talon Intramedullary Hip NailOrthopedic Designs, Inc. · 2002
  • K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999

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/K972722 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972722: Ultimate Compression 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/K972722

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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