510(k) Report

510(k) · Cleared

Cleared

Odi Compression Hip Screw System

K971993510(k) TraditionalCleared Nov 12, 1997167-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Orthopaedic Designs, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Nov 12, 1997 as substantially equivalent to K781762 (Howmedica Corp., 1978) and 9 other predicates after a 167-day review. Its family tree reaches back 2 generations to 1985.

Decided
Nov 12, 1997
Review
167 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
10

Its longest line of descent runs back 2 generations to K850886 (1985). 11 ancestors in all, the oldest K781762 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1992: 1 other ancestor1990: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor1982: 1 other ancestor1979: 1 other ancestor1978: 1 other ancestor1994: 1 other ancestorK850886 · Compression Hip Screw System · Pfizer, Inc. · 1985 · recalledK955306 · Omega+ Compression Screw System · Howmedica Corp. · 1996 · recalled19751980198519901995
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 1 other ancestor 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 deviceK971993 Odi Compression Hip Screw SystemOrthopaedic Designs, Inc. · 1997
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)K971993Odi Compression Hip Screw SystemOrthopaedic Designs, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197910
198210
198610
198710
199010
199210
199410
199510
FIG. 1 — Lineage of K971993, 1985–1997Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.4 · 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? (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 Sideplate (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 Sideplate (K823548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica O…
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 Sideplate (K823548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K955306) rHowmedica…
Howmedica Corp.1990—
*K850886Compression Hip Screw System
Summary page 3
…rew System (K781762) Howmedica Compression Hip Screw Sideplate (K823548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K955306) rHowmedica Omega Plus Compression Hip System (K922295) Synthe…
Pfizer, Inc.19851
*K872223Modified Omega Compression Hip Screw System
Summary page 3
…(K781762) Howmedica Compression Hip Screw Sideplate (K823548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K955306) rHowmedica Omega Plus Compression Hip System (K922295) Synthes DHS Hip S…
Howmedica Corp.19871
*K955306Omega+ Compression Screw System
Summary page 3
…3548) Howmedica Alta Lag Screw & Compression Screw (K900584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K955306) rHowmedica Omega Plus Compression Hip System (K922295) Synthes DHS Hip Screw (K791619) Ace Cannulated Hip Screw and Captured Hip…
Howmedica Corp.19961
*K922295Omega Plus Compress Hip Screw System, Modification
Summary page 3
…0584) Howmedica Omega Compression Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K955306) rHowmedica Omega Plus Compression Hip System (K922295) Synthes DHS Hip Screw (K791619) Ace Cannulated Hip Screw and Captured Hip Screw System Richards KeylLock System Richards Kwik-K…
Howmedica Corp.19921
*K791619Dynamic Hip Screw
Summary page 3
…n Screw System (K850886), (K872223) Howmedica Omega+ Compression Hip Screw System (K955306) rHowmedica Omega Plus Compression Hip System (K922295) Synthes DHS Hip Screw (K791619) Ace Cannulated Hip Screw and Captured Hip Screw System Richards KeylLock System Richards Kwik-Key Richards Ambi Compression Hi…
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 use for intertrochante…
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 use for intertrochanteric fractur…
Depuy, Inc.1995—
*—Ace Cannulated Hip Screw and Captured Hip Screw System
Named without a submission number
—
*—Richards Key-Lock 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) 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?

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 12 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
  • 5 of the 11 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K781762.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The ODi Compression Hip Screw System 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, some high subtrochanteric fractures and intracapsular fractures, provided that weight bearing is not allowed until the fracture shows evidence of union. The device is intended to stabilize fragments of the fracture until bony union can occur.

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
  • K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999

More from Orthopaedic Designs, Inc.

2 FDA decisions under this applicant name. See the company

  • K880737Self Guiding (SG) Interlocking NailOrthopaedic Designs, Inc. · 1988

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The KTT category page

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https://510kreport.com/device/K971993 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971993: Odi Compression Hip 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/K971993

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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