510(k) Report

510(k) · Cleared

Cleared

Ace 100 Degrees Tubular Plate

K920738510(k) TraditionalCleared Jul 27, 1992159-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

Ace Orthopedic Manufacturing Co. · HRS Plate, Fixation, Bone

Cleared on Jul 27, 1992 after a 159-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 346 later devices descend from it.

Decided
Jul 27, 1992
Review
159 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

346 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2012: 15 descendants cleared2025: 25 descendants cleared2005: 1 descendant cleared2008: 1 descendant cleared2010: 4 descendants cleared2011: 2 descendants cleared2014: 13 descendants cleared2017: 29 descendants cleared2015: 24 descendants cleared2019: 19 descendants cleared2023: 28 descendants cleared2021: 24 descendants cleared2024: 39 descendants cleared2018: 15 descendants cleared2013: 5 descendants cleared2020: 27 descendants cleared2026: 38 descendants cleared2016: 13 descendants cleared2022: 24 descendants cleared1990200020102020
  1. This deviceK920738 Ace 100 Degrees Tubular PlateAce Orthopedic Manufacturing Co. · 1992
  2. Descendant · cites it directly · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
  3. Descendant · 2 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
  4. Descendant · 3 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  5. Descendant · 3 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  6. Descendant · 3 generations on · 119 of its ownK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled

Showing 5 of 346 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12010: 42011: 22012: 152013: 52014: 132015: 242016: 132017: 292018: 152019: 192020: 272021: 242022: 242023: 282024: 392025: 252026: 38
2005high 39 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 346 · See all
  • K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · cites it directly343descendants
  • K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 2 generations on342descendants
  • K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 3 generations on339descendants
  • K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 3 generations on228descendants
  • K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc. · 2010 · 3 generations on119descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920738Ace 100 Degrees Tubular PlateAce Orthopedic Manufacturing Co.1992—
+1K050868MaxlockOrthohelix Surgical Designs, Inc.2005—
+2K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081
+3K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
+3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
+3K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
201040
201120
2012150
201350
2014130
2015240
2016130
2017290
2018150
2019190
2020270
2021240
2022240
2023280
2024390
2025250
2026380
FIG. 1 — Lineage of K920738, 1992–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (346)

See all 346

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

NumberDeviceApplicantDecidedDescendants
K050868MaxlockOrthohelix Surgical Designs, Inc.2005343
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121
K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250

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, K050868 (Orthohelix Surgical Designs, Inc., 2005) has gone furthest, with 343 descendants of its own.

How does its category compare?

All HRS devices

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

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

More from Ace Orthopedic Manufacturing Co.

14 FDA decisions under this applicant name. See the company

  • K934643Ace Humeral NailAce Orthopedic Manufacturing Co. · 1994
  • K934962Aim Supracondylar NailAce Orthopedic Manufacturing Co. · 1994
  • K936045Ace Unilateral Fixator IIAce Orthopedic Manufacturing Co. · 1994
  • K926047Ace 8.0MM Cannulated Cancellous Bone ScrewAce Orthopedic Manufacturing Co. · 1993
  • K813554Ace/Kyle Captured Hip ScrewAce Orthopedic Manufacturing Co. · 1982

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https://510kreport.com/device/K920738 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920738: Ace 100 Degrees Tubular Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920738

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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