510(k) Report

510(k) · Cleared

Cleared

Alphatec Compression and Reconstruction Plates

K933112510(k) TraditionalCleared Feb 17, 1994237-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

Alphatec Mfg., Inc. · HRS Plate, Fixation, Bone

Cleared on Feb 17, 1994 after a 237-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Feb 17, 1994
Review
237 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2002: 1 descendant cleared2005: 3 descendants cleared2004: 1 descendant cleared2007: 2 descendants cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK933112 Alphatec Compression and Reconstruction PlatesAlphatec Mfg., Inc. · 1994
  2. Descendant · cites it directly · 8 of its ownK972219 Orthopedic Plate SystemFerguson Medical · 1997
  3. Descendant · 2 generations on · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
  4. Descendant · 3 generations on · 1 of its ownK063709 TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007
  5. Descendant · 3 generations on · 1 of its ownK040850 Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004
  6. Descendant · 4 generations on · 0 of its ownK072175 Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1997: 12002: 12004: 12005: 32006: 12007: 2
1997high 3 (2005) · low 0 (1998)2026

Most influential descendants

Showing 5 of 9 · See all
  • K972219Orthopedic Plate SystemFerguson Medical · 1997 · cites it directly8descendants
  • K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · 2 generations on7descendants
  • K063709TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007 · 3 generations on1descendant
  • K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004 · 3 generations on1descendant
  • K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933112Alphatec Compression and Reconstruction PlatesAlphatec Mfg., Inc.1994—
+1K972219Orthopedic Plate SystemFerguson Medical1997—
+2K022139Hip Tool ImplantOrthopedic Sciences, Inc.2002—
+3K063709TS-Bone Hip ToolOrthopedic Sciences, Inc.2007—
+3K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc.2004—
+4K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200410
200530
200610
200720
FIG. 1 — Lineage of K933112, 1994–2007Source: 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), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K972219Orthopedic Plate SystemFerguson Medical19978

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, K972219 (Ferguson Medical, 1997) has gone furthest, with 8 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 Alphatec Mfg., Inc.

20 FDA decisions under this applicant name. See the company

  • K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 20041 recall
  • K023299Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002
  • K020356Alpha Mirage Top Tightening Spinal SystemAlphatec Mfg., Inc. · 2002
  • K993513Deltaloc Anterior Cervical Plate SystemAlphatec Mfg., Inc. · 2000
  • K993873Alphatec External Fixation System Compression/Distraction RodAlphatec Mfg., Inc. · 2000

Recent decisions in HRS

The HRS category page

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  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
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  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K933112 · printed Nov 4, 2026

Cite this page

510(k) Report. “K933112: Alphatec Compression and Reconstruction Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933112

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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