510(k) · Cleared
ClearedHall Versipower Surgical Instrument System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Sep 15, 1989 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 15, 1989
- Review
- 35 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK895198 Hall Versipower Surgical Instrument SystemZimmer, Inc. · 1989
- Descendant · cites it directly · 2 of its ownK981269 Universal Drive SystemLinvatec Corp. · 1998 · Recalled
- Descendant · cites it directly · 1 of its ownK083830 Oscar Bone ResectorOrthosonics, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK093805 OSCAR 3Orthosonics, Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK012630 Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK012613 Reprocssed Linvatec ShaversAlliance Medical, Inc. · 2001 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K981269Universal Drive SystemLinvatec Corp. · 1998 · cites it directly2descendants
- K083830Oscar Bone ResectorOrthosonics, Ltd. · 2009 · cites it directly1descendant
- K093805OSCAR 3Orthosonics, Ltd. · 2010 · 2 generations on0descendants
- K012630Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc. · 2001 · 2 generations on0descendants
- K012613Reprocssed Linvatec ShaversAlliance Medical, Inc. · 2001 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895198 | Hall Versipower Surgical Instrument System | Zimmer, Inc. | 1989 | — |
| +1 | K981269 | Universal Drive System | Linvatec Corp. | 1998 | 3 |
| +1 | K083830 | Oscar Bone Resector | Orthosonics, Ltd. | 2009 | — |
| +2 | K093805 | OSCAR 3 | Orthosonics, Ltd. | 2010 | — |
| +2 | K012630 | Reprocessed Linvatec Arthroscopic Burs | Alliance Medical, Inc. | 2001 | — |
| +2 | K012613 | Reprocssed Linvatec Shavers | Alliance Medical, Inc. | 2001 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 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?
- Of its descendants, K981269 (Linvatec Corp., 1998) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HWE devicesHWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HWE
Too few HWE 510(k)s in any year since 2007 to give a median.
Recalls per year · HWE
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWE
2,848in 2025
MAUDE reports naming product code HWE, 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 | 1 | — | 0 | 123 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 4 | 180 |
| 2010 | 0 | — | 2 | 297 |
| 2011 | 1 | — | 2 | 138 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 1,243 |
| 2014 | 0 | — | 3 | 3,794 |
| 2015 | 1 | — | 5 | 5,567 |
| 2016 | 0 | — | 2 | 4,974 |
| 2017 | 0 | — | 1 | 5,074 |
| 2018 | 0 | — | 0 | 3,589 |
| 2019 | 0 | — | 0 | 3,452 |
| 2020 | 0 | — | 0 | 3,248 |
| 2021 | 0 | — | 0 | 3,140 |
| 2022 | 0 | — | 0 | 3,327 |
| 2023 | 0 | — | 0 | 3,397 |
| 2024 | 0 | — | 0 | 3,686 |
| 2025 | 0 | — | 0 | 2,848 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K895198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K895198: Hall Versipower Surgical Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895198
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026