510(k) Report

510(k) · Cleared

Cleared

Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System

K182468510(k) TraditionalCleared Mar 19, 2019190-day reviewClass II21 CFR 888.3358

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

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Mar 19, 2019 as substantially equivalent to K033716 (Howmedica Osteonics Corp., 2005) and 8 other predicates after a 190-day review. Its family tree reaches back 9 generations to 1994. 7 later devices descend from it.

Decided
Mar 19, 2019
Review
190 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
9

Its longest line of descent runs back 9 generations to K921308 (1994). 119 ancestors in all, the oldest K894124 (1989). 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 5 other ancestors2009: 2 other ancestors2006: 4 other ancestors2005: 7 other ancestors2015: 1 other ancestor2014: 1 other ancestor2013: 1 other ancestor2012: 1 other ancestor2008: 1 other ancestor2007: 2 other ancestors2004: 3 other ancestors2003: 5 other ancestors2002: 11 other ancestors2001: 6 other ancestors2000: 11 other ancestors1999: 5 other ancestors1998: 7 other ancestors1997: 6 other ancestors1995: 9 other ancestors1994: 7 other ancestors1992: 2 other ancestors1991: 4 other ancestors1990: 2 other ancestors1989: 1 other ancestor1996: 6 other ancestors2025: 3 descendants cleared2023: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant clearedReference device: K172634 · Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · recalledReference device: K983502 · Osteonics Secur-Fit AD Generation II Acetabular Component System · Osteonics Corp. · 1998 · recalledReference device: K983382 · Osteonics HA Generation II Acetabular Component System · Osteonics Corp. · 1998 · recalledReference device: K072020 · Restoration Adm System · Howmedica Osteonics Corp. · 2007 · recalledK921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK103479 · Novel Tapered Hip Stem · Stryker Corp. · 2011K120578 · Accolade II Hip Stem · Howmedica Osteonics · 2012 · recalledK122853 · Novel Fit and Fill Stem · Howmedica Osteonics Corp. · 2013K143085 · Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach · Stryker Orthopaedics · 2015 · recalledK153345 · Stryker Orthopaedics Hip Systems Labeling Update · Stryker Orthopaedics · 2016 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 56 other ancestors3 generations back: 28 other ancestors4 generations back: 17 other ancestors5 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants K153345 · Stryker Orthopaedics Hip Systems Labeling Update · Stryker Orthopaedics · 2016 · recalledK143085 · Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach · Stryker Orthopaedics · 2015 · recalledK122853 · Novel Fit and Fill Stem · Howmedica Osteonics Corp. · 2013K120578 · Accolade II Hip Stem · Howmedica Osteonics · 2012 · recalledK103479 · Novel Tapered Hip Stem · Stryker Corp. · 2011K013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalled−50
  1. Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
  2. 5 generations between
  3. 3 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
  4. 2 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
  5. 1 generation backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
  6. This deviceK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
  7. Descendant · cites it directly · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  8. Descendant · 2 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  9. Descendant · 2 generations on · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled
  10. Descendant · 2 generations on · 0 of its ownK250989 Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025
  11. Descendant · cites it directly · 0 of its ownK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
Show all 9 generations
  1. Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
  2. 8 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
  3. 7 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
  4. 6 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  5. 5 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
  6. 4 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
  7. 3 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
  8. 2 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
  9. 1 generation backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
  10. This deviceK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2023: 12024: 22025: 32026: 1
2023high 3 (2025) · low 1 (2023)2026

Most influential descendants

Showing 5 of 7 · See all
  • K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
  • K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on2descendants
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 2 generations on0descendants
  • K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025 · 2 generations on0descendants
  • K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K921308HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc.19941
−8K972893Partnership Revision Femoral StemsHowmedica Corp.1997—
−7K983404Type 3 Femoral ComponentsHowmedica Corp.19981
−6K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
−5K103479Novel Tapered Hip StemStryker Corp.2011—
−4K120578Accolade II Hip StemHowmedica Osteonics20121
−3K122853Novel Fit and Fill StemHowmedica Osteonics Corp.2013—
−2K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics20152
−1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics20161
0 (this device)K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019—
+1K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023—
+2K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
+2K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20262
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)2025—
+1K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199020
199140
199220
199470
199590
199660
199760
199870
199950
2000110
200160
2002110
200350
200430
200570
200640
200720
200810
200920
201150
201210
201310
201410
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202420
202530
202610
FIG. 1 — Lineage of K182468, 1994–2026Source: 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), 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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (9)

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
*K033716Trident Acetabular System
Summary page 6
…roduct Codes: LPH, JDI, MEH, LZO, KWL, KWY, KWZ, LWJ Legally Marketed Devices to Which Substantial Equivalence is Claimed: • Trident® X3® Acetabular Inserts (K033716, K061434, K062419, K153345) • Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, K153345)…
Howmedica Osteonics Corp.20052
*K061434Trident Large Diameter Hip System
Summary page 6
…des: LPH, JDI, MEH, LZO, KWL, KWY, KWZ, LWJ Legally Marketed Devices to Which Substantial Equivalence is Claimed: • Trident® X3® Acetabular Inserts (K033716, K061434, K062419, K153345) • Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, K153345) • Accolad…
Howmedica Osteonics Corp.20062
*K062419Trident Large Diameter Acetabular Inserts
Summary page 6
…LPH, JDI, MEH, LZO, KWL, KWY, KWZ, LWJ Legally Marketed Devices to Which Substantial Equivalence is Claimed: • Trident® X3® Acetabular Inserts (K033716, K061434, K062419, K153345) • Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, K153345) • Accolade® II Hip…
Howmedica Osteonics Corp.2006—
*K153345Stryker Orthopaedics Hip Systems Labeling Update
Summary page 6
…JDI, MEH, LZO, KWL, KWY, KWZ, LWJ Legally Marketed Devices to Which Substantial Equivalence is Claimed: • Trident® X3® Acetabular Inserts (K033716, K061434, K062419, K153345) • Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, K153345) • Accolade® II Hip System (…
Stryker Orthopaedics20161
*K093644Restoration Adm System X3 Acetabular
Summary page 6
…hich Substantial Equivalence is Claimed: • Trident® X3® Acetabular Inserts (K033716, K061434, K062419, K153345) • Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, K153345) • Accolade® II Hip System (K103479, K120578, K153345) Legally Marketed Reference Devices U…
Howmedica Osteonics Corp.20091
*K103233Modular Dual Mobility Liner, X3 Acetabular Insert
Summary page 6
…tantial Equivalence is Claimed: • Trident® X3® Acetabular Inserts (K033716, K061434, K062419, K153345) • Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, K153345) • Accolade® II Hip System (K103479, K120578, K153345) Legally Marketed Reference Devices Used to Su…
Howmedica Osteonics Corp.20111
*K112556Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts
Summary page 6
…quivalence is Claimed: • Trident® X3® Acetabular Inserts (K033716, K061434, K062419, K153345) • Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, K153345) • Accolade® II Hip System (K103479, K120578, K153345) Legally Marketed Reference Devices Used to Support Sub…
Howmedica Osteonics Corp.20111
*K103479Novel Tapered Hip Stem
Summary page 6
…erts (K033716, K061434, K062419, K153345) • Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, K153345) • Accolade® II Hip System (K103479, K120578, K153345) Legally Marketed Reference Devices Used to Support Substantial Equivalence: • Triathlon® X3® UHMWPE Tibial…
Stryker Corp.2011—
*K120578Accolade II Hip Stem
Summary page 6
…3716, K061434, K062419, K153345) • Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, K153345) • Accolade® II Hip System (K103479, K120578, K153345) Legally Marketed Reference Devices Used to Support Substantial Equivalence: • Triathlon® X3® UHMWPE Tibial Inserts…
Howmedica Osteonics20121
†K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20177
†K983502Osteonics Secur-Fit AD Generation II Acetabular Component SystemOsteonics Corp.19981
†K983382Osteonics HA Generation II Acetabular Component SystemOsteonics Corp.19984
†K072020Restoration Adm SystemHowmedica Osteonics Corp.20071

Also cleared against K033716: 4 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234
K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250
K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240

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 25 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
  • 44 of the 119 ancestors have a recall of any class.
  • Of its descendants, K233498 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2023) has gone furthest, with 4 descendants of its own.
  • 4 other devices also cite its predicate K033716.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

Trident Acetabular Component System Indications for Use: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory…

Read the full statement (311 words)

Trident Acetabular Component System

Indications for Use:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.

• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Restoration ADM Acetabular Cup and MDM Liner Systems

The indications for use for total hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

2. Rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and,

5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

6. Dislocation risks

RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only.

Accolade II Hip System

The indications for use of the total hip replacement prostheses include:

1. Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

2. Rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and,

5. Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:

1. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for use as stated in the FDA summary.

Also cleared against K033716

4 other devices cite the same predicate.

  • K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall
  • K062419Trident Large Diameter Acetabular InsertsHowmedica Osteonics Corp. · 2006
  • K061434Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 20062 recalls

More from Howmedica Osteonics Corp. A.K.A.…

9 FDA decisions under this applicant name. See the company

  • K233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2023
  • K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2021
  • K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2020
  • K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
  • K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2018

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K182468 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182468

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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