510(k) Report

510(k) · Cleared

Cleared

Odi Ultimate Compression Hip Screw

K984331510(k) TraditionalCleared Jan 20, 199948-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 20, 1999 as substantially equivalent to K781762 (Howmedica Corp., 1978) and 9 other predicates after a 48-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.

Decided
Jan 20, 1999
Review
48 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
10

Its longest line of descent runs back 2 generations to K850886 (1985). 12 ancestors in all, the oldest K781762 (1978). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1992: 2 other ancestors1990: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor1982: 1 other ancestor1979: 1 other ancestor1978: 1 other ancestor1994: 1 other ancestor2004: 1 descendant cleared2011: 1 descendant cleared2023: 1 descendant clearedK850886 · Compression Hip Screw System · Pfizer, Inc. · 1985 · recalledK955306 · Omega+ Compression Screw System · Howmedica Corp. · 1996 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K955306 · Omega+ Compression Screw System · Howmedica Corp. · 1996 · recalledK850886 · Compression Hip Screw System · Pfizer, Inc. · 1985 · recalled0
  1. Root · 2 generations backK850886 Compression Hip Screw SystemPfizer, Inc. · 1985 · Recalled
  2. 1 generation backK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996 · Recalled
  3. This deviceK984331 Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
  4. Descendant · cites it directly · 2 of its ownK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004
  5. Descendant · 2 generations on · 1 of its ownK111352 Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011
  6. Descendant · 3 generations on · 0 of its ownK223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023

Most influential descendants

Showing 3 of 3 · See all
  • K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004 · cites it directly2descendants
  • K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011 · 2 generations on1descendant
  • K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K850886Compression Hip Screw SystemPfizer, Inc.19851
−1K955306Omega+ Compression Screw SystemHowmedica Corp.19961
0 (this device)K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc.1999—
+1K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)2004—
+2K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.2011—
+3K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197910
198210
198610
198710
199010
199220
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201110
202310
FIG. 1 — Lineage of K984331, 1985–2023Source: 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
Get a 510(k) Report

What was it cleared against? (22)

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
*K781762Compression Hip Screw System
Summary page 3
…ture and method of sterilization. Within the proposed class, the following devices are used as predicate devices for comparison: Howmedica Compression Hip Screw System (K781762) Howmedica Compression Hip Screw Sidepiate (K823548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compr…
Howmedica Corp.1978—
*K823548Compression Hip Screw Side-Plate
Summary page 3
…d class, the following devices are used as predicate devices for comparison: Howmedica Compression Hip Screw System (K781762) Howmedica Compression Hip Screw Sidepiate (K823548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica…
Howmedica Corp.1982—
*K900584Alta Lag Screw and Compression Screw
Summary page 3
…vices for comparison: Howmedica Compression Hip Screw System (K781762) Howmedica Compression Hip Screw Sidepiate (K823548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K855306) Howmedica…
Howmedica Corp.1990—
*K850886Compression Hip Screw System
Summary page 3
…rew System (K781762) Howmedica Compression Hip Screw Sidepiate (K823548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K855306) Howmedica Omega Plus Compression Hip System (K922285) Synthe…
Pfizer, Inc.19851
*K872223Modified Omega Compression Hip Screw System
Summary page 3
…K781762) Howmedica Compression Hip Screw Sidepiate (K823548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K855306) Howmedica Omega Plus Compression Hip System (K922285) Synthes DHS Hip Sc…
Howmedica Corp.19871
*K955306Omega+ Compression Screw System
Our OCR of the scanned summary read K855306, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Howmedica Omega+ Compression Hip Screw System”.
Howmedica Corp.19961
*K922285Agc and Maxim Knee Components with NTS
Summary page 3
…0584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K855306) Howmedica Omega Plus Compression Hip System (K922285) Synthes DHS Hip Screw (K791619) 33 Substantial Equivalent Devices continued: Ace Cannulated Hip Screw and Capt…
Biomet, Inc.1992—
*K791619Dynamic Hip Screw
Summary page 3
…n Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K855306) Howmedica Omega Plus Compression Hip System (K922285) Synthes DHS Hip Screw (K791619) 33 Substantial Equivalent Devices continued: Ace Cannulated Hip Screw and Captured Hip Screw System Richards…
Synthes (Usa)1979—
*K861178Depuy Compression Hip Screw System
Summary page 4
…Hip Compression Screw/Plate Wright Concise Compression Hip Screw System Wright Cannulated Plus Screw System Depuy Combined NolLok /Keyed Compression Hip Screw System (K861178), (K946156) Each of these products are commercially available and marketed Class Il devices indicated for similar use. 34 ===…
Depuy, Inc.1986—
*K946156Depuy Compression Hip Screw System
Summary page 4
…sion Screw/Plate Wright Concise Compression Hip Screw System Wright Cannulated Plus Screw System Depuy Combined NolLok /Keyed Compression Hip Screw System (K861178), (K946156) Each of these products are commercially available and marketed Class Il devices indicated for similar use. 34…
Depuy, Inc.1995—
*—Ace Cannulated Hip Screw and Captured Hip Screw System
Named without a submission number
—
*—Richards KeyLock System
Named without a submission number
—
*—Richards Kwik-Key
Named without a submission number
—
*—Richards Ambi Compression Hip Screw
Named without a submission number
—
*—Richards Classic
Named without a submission number
—
*—Zimmer Compression Hip Screw with ECT
Named without a submission number
—
*—Zimmer Free-Lock
Named without a submission number
—
*—Zimmer Versa-Fx
Named without a submission number
—
*—Orthopedic Equipment Company’s (OECO.C.) Compression Hip Screw Plate
Named without a submission number
—
*—Wright Hip Compression Screw/Plate
Named without a submission number
—
*—Wright Concise Compression Hip Screw System
Named without a submission number
—
*—Wright Cannulated Plus Screw System
Named without a submission number
—

Also cleared against K781762: 2 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)20042

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 14 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
  • 5 of the 12 ancestors have a recall of any class.
  • Of its descendants, K033286 (Orthopedic Designs, Inc. (Odi), 2004) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K781762.

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 Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.

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 K781762

2 other devices cite the same predicate.

  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
  • K971993Odi Compression Hip Screw SystemOrthopaedic Designs, Inc. · 1997

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
  • K972722Ultimate Compression Screw SystemOrthopedic Designs, Inc. · 1998

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/K984331 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984331: Odi Ultimate Compression Hip Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984331

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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