510(k) · Cleared
ClearedFS 1000 Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renaissance Instruments, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 10, 1999 after a 225-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it.
- Decided
- Nov 10, 1999
- Review
- 225 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK991052 FS 1000 Knee SystemRenaissance Instruments, LLC · 1999
- Descendant · cites it directly · 20 of its ownK121416 GMK SphereMedacta International · 2012
- Descendant · 2 generations on · 17 of its ownK140826 GMK Sphere ExtensionMedacta International · 2014
- Descendant · 2 generations on · 10 of its ownK162035 GMK SphereMedacta International S.A. · 2017
- Descendant · 2 generations on · 6 of its ownK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- Descendant · 2 generations on · 4 of its ownK211004 GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A. · 2021
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K121416GMK SphereMedacta International · 2012 · cites it directly20descendants
- K140826GMK Sphere ExtensionMedacta International · 2014 · 2 generations on17descendants
- K162035GMK SphereMedacta International S.A. · 2017 · 2 generations on10descendants
- K173890GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018 · 2 generations on6descendants
- K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A. · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991052 | FS 1000 Knee System | Renaissance Instruments, LLC | 1999 | — |
| +1 | K121416 | GMK Sphere | Medacta International | 2012 | — |
| +2 | K140826 | GMK Sphere Extension | Medacta International | 2014 | — |
| +2 | K162035 | GMK Sphere | Medacta International S.A. | 2017 | — |
| +2 | K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018 | — |
| +2 | K211004 | GMK Spherika Femurs and Fixed Tibial Trays Plus | Medacta International S.A. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (23)
See all 232 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, K121416 (Medacta International, 2012) has gone furthest, with 20 descendants of its own.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The FS 1000 Knee System is intended for single-use cemented implantation for use in
total knee arthroplasty surgery for reduction or relief of pain and/or improved knee function
in skeletally mature patients with the following conditions:
Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic
arthritis, or avascular necrosis;
Inflammatory degenerative joint disease including rheumatoid arthritis;
Correction of varus, valgus, or post traumatic deformity;
Correction or revision of unsuccessful osteotomy or arthrodesis;
Revision procedures where other treatments or devices have failed; and
Treatment of fractures that are unmanageable using other techniques;
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991052: FS 1000 Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991052
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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