510(k) · Cleared
ClearedEberle Shaver System C2 and Shaver Blades
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Efs Eberle Feinwerktechnische Systeme · HRX Arthroscope
Cleared on Sep 1, 2006 as substantially equivalent to K973195 (Stryker Endoscopy, 1997) and 3 other predicates after a 130-day review. Its family tree reaches back 5 generations to 1986. 2 later devices descend from it.
- Decided
- Sep 1, 2006
- Review
- 130 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K862807 (1986). 20 ancestors in all, the oldest K852143 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 4 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 3 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 2 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 1 generation backK990524 E9000 SystemLinvatec Corp. · 1999
- This deviceK061134 Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme · 2006
- Descendant · cites it directly · 1 of its ownK092977 Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010
- Descendant · 2 generations on · 0 of its ownK193608 EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −4 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −3 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −2 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −1 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| 0 (this device) | K061134 | Eberle Shaver System C2 and Shaver Blades | Efs Eberle Feinwerktechnische Systeme | 2006 | — |
| +1 | K092977 | Eberle Shaver System Accessories | Efs Eberle Feinwerktechnische Systeme | 2010 | — |
| +2 | K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2021 | 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 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 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K973195 | Total Performance System ShaverSummary page 2…ble, sterile/ non-sterile). All these components are designed, constructed and intended to be operated exclusively as a unit. 6. Substantial Equivalence: K973195, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9000 System K00252… | 1997 |
| * | K030009 | Ksea Powershaver System S2Summary page 2…are designed, constructed and intended to be operated exclusively as a unit. 6. Substantial Equivalence: K973195, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9000 System K002523, Linvatec Advantage Drive System 7. Description of… | 2003 |
| * | K990524 | E9000 SystemSummary page 2…be operated exclusively as a unit. 6. Substantial Equivalence: K973195, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9000 System K002523, Linvatec Advantage Drive System 7. Description of Safety: The selection of the materia… | 1999 |
| * | K002523 | Advantage Drive SystemSummary page 2…nit. 6. Substantial Equivalence: K973195, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9000 System K002523, Linvatec Advantage Drive System 7. Description of Safety: The selection of the materials for the EBERLE Shaver System C2 a… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092977 | Eberle Shaver System Accessories | 2010 | 1 |
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 20 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K092977 (Efs Eberle Feinwerktechnische Systeme, 2010) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K973195.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The EBERLE Shaver System C2 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone conducted by qualified surgeons only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061134: Eberle Shaver System C2 and Shaver Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061134
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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