510(k) Report

510(k) · Cleared

Recalled · 2008

Stryker Surgical Instruments and Accessories

K943323510(k) TraditionalCleared Nov 28, 1994140-day reviewClass II21 CFR 888.1100Recalls 10

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

Stryker Corp. · HRX Arthroscope

Cleared on Nov 28, 1994 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 33 later devices descend from it. It has been recalled 10 times.

Decided
Nov 28, 1994
Review
140 days
Class
Class II
Product code
HRX
Recalls
10
Predicates
0

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

Descendants, by year cleared 2012: 1 descendant cleared2015: 1 descendant cleared2020: 5 descendants cleared2017: 4 descendants cleared2023: 4 descendants cleared2019: 2 descendants cleared2018: 2 descendants cleared2026: 3 descendants cleared2024: 6 descendants cleared2025: 2 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK943323 Stryker Surgical Instruments and AccessoriesStryker Corp. · 1994
  2. Descendant · cites it directly · 32 of its ownK120434 Power Adaptor Instrument AccessoryStryker Corp. · 2012
  3. Descendant · 2 generations on · 31 of its ownK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
  4. Descendant · 3 generations on · 15 of its ownK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
  5. Descendant · 3 generations on · 12 of its ownK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
  6. Descendant · 3 generations on · 9 of its ownK172724 XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation · 2017

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2012: 12015: 12017: 42018: 22019: 22020: 52021: 12022: 22023: 42024: 62025: 22026: 3
2012high 6 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 33 · See all
  • K120434Power Adaptor Instrument AccessoryStryker Corp. · 2012 · cites it directly32descendants
  • K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015 · 2 generations on31descendants
  • K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · 3 generations on15descendants
  • K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017 · 3 generations on12descendants
  • K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation · 2017 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943323Stryker Surgical Instruments and AccessoriesStryker Corp.1994—
+1K120434Power Adaptor Instrument AccessoryStryker Corp.2012—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation2015—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation20171
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation2017—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
201740
201820
201920
202050
202110
202220
202340
202460
202520
202630
FIG. 1 — Lineage of K943323, 1994–2026Source: 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 HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K120434Power Adaptor Instrument AccessoryStryker Corp.201232

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 10, 2008Not classifiedZ-1022-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008Not classifiedZ-1023-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008Not classifiedZ-1021-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008Not classifiedZ-1029-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008Not classifiedZ-1026-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008Not classifiedZ-1027-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008Not classifiedZ-1024-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008Not classifiedZ-1025-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008Not classifiedZ-1028-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008Not classifiedZ-1030-2009Component design/selectionThe handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.

The 5 latest of 10 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K120434 (Stryker Corp., 2012) has gone furthest, with 32 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

More from Stryker Corp.

156 FDA decisions under this applicant name. See the company

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  • K191259Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp. · 2019
  • K182359HipCheckStryker Corp. · 2018
  • P050044/S033Vitagel RT3 Sutgical HemostatStryker Corp. · 2017
  • P050044/S032Vitagel RT3 Surgical HemostatStryker Corp. · 2015

Recent decisions in HRX

The HRX category page

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  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
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https://510kreport.com/device/K943323 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943323: Stryker Surgical Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943323

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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