510(k) · Cleared
ClearedRelign System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Relign Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 4, 2017 as substantially equivalent to K071859 (Stryker Endoscopy, 2007) and 1 other predicate after a 93-day review. Its family tree reaches back 8 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 4, 2017
- Review
- 93 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K011083 (2001). 47 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 7 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 6 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 5 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 4 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 3 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 2 generations backK041810 Serfas Energy SystemStryker Endoscopy · 2004 · Recalled
- 1 generation backK071859 Stryker Crossfire SystemStryker Endoscopy · 2007 · Recalled
- This deviceK162770 Relign SystemRelign Corporation · 2017
- Descendant · cites it directly · 1 of its ownK233493 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation · 2023
- Descendant · cites it directly · 0 of its ownK241008 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation, Subsidiary of Zimmer Biomet · 2024
Most influential descendants
Showing 2 of 2 · See all- K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation · 2023 · cites it directly1descendant
- K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −7 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −6 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −5 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −4 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −3 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −2 | K041810 | Serfas Energy System | Stryker Endoscopy | 2004 | 3 |
| −1 | K071859 | Stryker Crossfire System | Stryker Endoscopy | 2007 | 2 |
| 0 (this device) | K162770 | Relign System | Relign Corporation | 2017 | — |
| +1 | K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver… | Relign Corporation | 2023 | — |
| +1 | K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece… | Relign Corporation, Subsidiary of Zimmer Biomet | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071859 | Stryker Crossfire SystemSummary page 4…878.4400); and Arthroscope and Accessories (21 CFR 888.1100) Product Code: GEI, HRX 4. Predicate Devices: K071859 Stryker Crossfire Integrated Arthroscopy System K123441 Stryker CrossFlow Integrated Arthroscopy Pump 5.… | 2007 |
| * | K123441 | Stryker Crossflow Arthroscopy PumpSummary page 4…ries (21 CFR 888.1100) Product Code: GEI, HRX 4. Predicate Devices: K071859 Stryker Crossfire Integrated Arthroscopy System K123441 Stryker CrossFlow Integrated Arthroscopy Pump 5. Device Description: The Relign Arthroscopic System is a comb… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 9 of the 47 ancestors have a recall of any class.
- Of its descendants, K233493 (Relign Corporation, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K071859.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign 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 Relign Arthroscopic System provides abrasion, resection, debridement, and removal of bone through…
Read the full statement (134 words)
The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign 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 Relign 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 as stated in the FDA summary.
https://510kreport.com/device/K162770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162770: Relign System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162770
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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