510(k) · Cleared
ClearedImplex Continuum Knee- Hedrocel Revision Femoral Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implex Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 22, 1998 after an 81-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- May 22, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK980781 Implex Continuum Knee- Hedrocel Revision Femoral SpacersImplex Corp. · 1998
- Descendant · cites it directly · 11 of its ownK103517 Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 3 of its ownK200653 AMF Revision TT ConesLima Corporate S.P.A. · 2020
- Descendant · 3 generations on · 1 of its ownK240324 EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis) · 2024
- Descendant · 3 generations on · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K103517Trabecular Metal Femoral Cone AugmentsZimmer Trabecular Metal Technology, Inc. · 2011 · cites it directly11descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 2 generations on4descendants
- K200653AMF Revision TT ConesLima Corporate S.P.A. · 2020 · 2 generations on3descendants
- K240324EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis) · 2024 · 3 generations on1descendant
- K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980781 | Implex Continuum Knee- Hedrocel Revision Femoral Spacers | Implex Corp. | 1998 | — |
| +1 | K103517 | Trabecular Metal Femoral Cone Augments | Zimmer Trabecular Metal Technology, Inc. | 2011 | — |
| +2 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +2 | K200653 | AMF Revision TT Cones | Lima Corporate S.P.A. | 2020 | — |
| +3 | K240324 | EMPOWR Revision Symmetric Knee Cones | Encore Medical, L.P. (Dba Enovis) | 2024 | — |
| +3 | K191625 | Persona Revision Knee System | Zimmer, Inc. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | — | Implex CKS Revision Femoral Spacers Named without a submission number | |
| * | — | Implex Continuum Porous Patella Named without a submission number | |
| * | — | Implex Hedrocel Acetabular Restrictor Named without a submission number | |
| † | K962468 | Hedrocel Acetabular Restrictor | 1997 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103517 | Trabecular Metal Femoral Cone Augments | 2011 | 11 |
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, K103517 (Zimmer Trabecular Metal Technology, Inc., 2011) has gone furthest, with 11 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 use of the Continuum Knee System Hedrocel Revision Femoral Spacers are indicated for:
a) For cemented use only.
b) Total Knee Replacement (TKR) in severely disabled joints as a result of degenerative arthritis;
c) Secondary revision of a previously unsuccessful revision femoral component;
d) Other knee problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results;
e) Trauma, or other fractures in which adequate bony fixation cannot be obtained;
f) Non-union of the proximal tibia; and
g) Salvage of a failed primary or secondary total knee or uni-knee arthroplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980781: Implex Continuum Knee- Hedrocel Revision Femoral Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980781
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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