510(k) · Cleared
ClearedEberle Shaver System Accessories
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 29, 2010 as substantially equivalent to K061134 (Efs Eberle Feinwerktechnische Systeme, 2006) and 5 other predicates after a 369-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Sep 29, 2010
- Review
- 369 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K931783 (1993). 39 ancestors in all, the oldest K771218 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 4 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 3 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 2 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 1 generation backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- This deviceK092977 Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010
- Descendant · cites it directly · 0 of its ownK193608 EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021
Most influential descendants
Showing 1 of 1 · See all- K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −5 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −4 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −3 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −2 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −1 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| 0 (this device) | K092977 | Eberle Shaver System Accessories | Efs Eberle Feinwerktechnische Systeme | 2010 | — |
| +1 | 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 |
|---|---|---|
| 1978 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061134 | Eberle Shaver System C2 and Shaver BladesSummary page 2…All these components are designed, constructed and intended to be operated exclusively as a unit with the Eberle Shaver System 02. 6. Substantial Equivalence: K061 134, Eberle Shaver System 02 and Shaver Blades K0321 17, Stryker Total Performance System Shaver K030009, KSEA Powershave… | 2006 |
| * | K032117 | Stryker Total Performance (TPS) SystemSummary page 2…d to be operated exclusively as a unit with the Eberle Shaver System 02. 6. Substantial Equivalence: K061 134, Eberle Shaver System 02 and Shaver Blades K0321 17, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9OOO System K00… | 2003 |
| * | K030009 | Ksea Powershaver System S2Summary page 2…le Shaver System 02. 6. Substantial Equivalence: K061 134, Eberle Shaver System 02 and Shaver Blades K0321 17, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9OOO System K002523, Linvatec Advantage Drive System K072706, Li… | 2003 |
| * | K990524 | E9000 SystemSummary page 2…alence: K061 134, Eberle Shaver System 02 and Shaver Blades K0321 17, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9OOO System K002523, Linvatec Advantage Drive System K072706, Linvatec Handpiece System K050617, Ric… | 1999 |
| * | K002523 | Advantage Drive SystemSummary page 2…System 02 and Shaver Blades K0321 17, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9OOO System K002523, Linvatec Advantage Drive System K072706, Linvatec Handpiece System K050617, Richard Wolf Power Driver ARTi === Page… | 2000 |
| * | K072706 | Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax High Speed…Summary page 2…ryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9OOO System K002523, Linvatec Advantage Drive System K072706, Linvatec Handpiece System K050617, Richard Wolf Power Driver ARTi 7. Description of Safety: * EMV… | 2007 |
| Kept off the family tree | K050617 | FDA’s K050617 is 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HB Our reading of the summary gave K050617, FDA’s number for 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A… (Totoku Electric Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Richard Wolf Power Driver ARTi”. Kept off the family tree. Summary page 2…K030009, KSEA Powershaver System S2 K990524, Linvatec E9OOO System K002523, Linvatec Advantage Drive System K072706, Linvatec Handpiece System K050617, Richard Wolf Power Driver ARTi 7. Description of Safety: * EMVC according IEC 60601-1-2 for not life su… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193608 | EBERLE Shaver System C3 and Accessories | 2021 | 0 |
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 17 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 39 ancestors have a recall of any class.
- Of its descendants, K193608 (Eberle GmbH & Co. KG, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Accessories are designed to use with the EBERLE Shaver System for arthroscopy surgical procedures like shaving, burring, abrading, cuffing, drilling 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/K092977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092977: Eberle Shaver System Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092977
Report an extraction error
Are you the manufacturer?
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