510(k) Report

510(k) · Cleared

Cleared

Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)

K241008510(k) SpecialCleared May 8, 202426-day reviewClass II21 CFR 878.4400

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

Relign Corporation, Subsidiary of Zimmer Biomet · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 8, 2024 as substantially equivalent to K233493 (Relign Corporation, 2023) and 1 other predicate after a 26-day review. Its family tree reaches back 10 generations to 2001.

Decided
May 8, 2024
Review
26 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 10 generations to K011083 (2001). 49 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor1997: 1 other ancestor2002: 1 other ancestor2001: 4 other ancestors2000: 4 other ancestors1999: 3 other ancestors1998: 6 other ancestors1995: 4 other ancestors1994: 5 other ancestors1978: 1 other ancestor1996: 5 other ancestors1993: 1 other ancestor1991: 1 other ancestor×3: 3 generations cleared close together, K011083 (2001), K013463 (2001), K020557 (2002) ×3: 3 generations cleared close together, K030551 (2003), K032504 (2003), K033584 (2003) K041810 · Serfas Energy System · Stryker Endoscopy · 2004 · recalledK071859 · Stryker Crossfire System · Stryker Endoscopy · 2007 · recalledK162770 · Relign System · Relign Corporation · 2017K233493 · Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) · Relign Corporation · 202319801990200020102020
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 14 other ancestors5 generations back: 13 other ancestors6 generations back: 6 other ancestors7 generations back: 2 other ancestors K233493 · Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) · Relign Corporation · 2023K162770 · Relign System · Relign Corporation · 2017K071859 · Stryker Crossfire System · Stryker Endoscopy · 2007 · recalledK041810 · Serfas Energy System · Stryker Endoscopy · 2004 · recalledK033584 · Arthrocare Arthrowands · Arthrocare Corp. · 2003 · recalledK032504 · Arthrocare System · Arthrocare Corp. · 2003K030551 · Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2003 · recalledK020557 · Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2002K013463 · Arthrocare Arthro Wands, Enetec Evac Plasma Wand · Arthrocare Corp. · 2001K011083 · Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand · Arthrocare Corp. · 2001−10−50
  1. Root · 10 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. 6 generations between
  3. 3 generations backK071859 Stryker Crossfire SystemStryker Endoscopy · 2007 · Recalled
  4. 2 generations backK162770 Relign SystemRelign Corporation · 2017
  5. 1 generation backK233493 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation · 2023
  6. This deviceK241008 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation, Subsidiary of Zimmer Biomet · 2024
Show all 10 generations
  1. Root · 10 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. 9 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
  3. 8 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
  4. 7 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
  5. 6 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
  6. 5 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
  7. 4 generations backK041810 Serfas Energy SystemStryker Endoscopy · 2004 · Recalled
  8. 3 generations backK071859 Stryker Crossfire SystemStryker Endoscopy · 2007 · Recalled
  9. 2 generations backK162770 Relign SystemRelign Corporation · 2017
  10. 1 generation backK233493 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation · 2023
  11. This deviceK241008 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation, Subsidiary of Zimmer Biomet · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K011083Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare…Arthrocare Corp.2001—
−9K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp.2001—
−8K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.2002—
−7K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot…Arthrocare Corp.20031
−6K032504Arthrocare SystemArthrocare Corp.2003—
−5K033584Arthrocare ArthrowandsArthrocare Corp.20031
−4K041810Serfas Energy SystemStryker Endoscopy20043
−3K071859Stryker Crossfire SystemStryker Endoscopy20072
−2K162770Relign SystemRelign Corporation2017—
−1K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver…Relign Corporation2023—
0 (this device)K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199110
199310
199450
199540
199650
199710
199860
199930
200040
200140
200210
200310
200410
201310
FIG. 1 — Lineage of K241008, 2001–2024Source: 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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (2)

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
*K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…
Summary page 6
…ccessories Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Product Code: GEI, HRX 510(K) Numbers: Primary Predicate-K233493 Additional Predicate-K162770 5. Device Description: The device description and principles of operation for the…
Relign Corporation2023—
*K162770Relign System
Summary page 6
…al Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Product Code: GEI, HRX 510(K) Numbers: Primary Predicate-K233493 Additional Predicate-K162770 5. Device Description: The device description and principles of operation for the modified devices are equivalent to the devic…
Relign Corporation2017—

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 23 years and passes through 4 companies; a new generation was cleared every 12 months on median.
  • 9 of the 49 ancestors have a recall of any class.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Tricera™ Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Tricera™ Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera™ Arthroscopic System provides abrasion, resection, debridement, and removal of bone…

Read the full statement (134 words)

The Tricera™ Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures.

The Fluid Management System of the Tricera™ Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera™ Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

Contraindications: The electrosurgical probe should not be used in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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https://510kreport.com/device/K241008 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241008: Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241008

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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