510(k) · Cleared
ClearedImplex Continuum Knee System: Porous Tibial Component Model Number 05-230 System
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 Jun 8, 1998 as substantially equivalent to K882322 (Buckman Co., Inc., 1989) and 3 other predicates after a 38-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jun 8, 1998
- Review
- 38 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K882322 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK882322 Continuum Knee System (CKS)Buckman Co., Inc. · 1989
- This deviceK981560 Implex Continuum Knee System: Porous Tibial Component Model Number…Implex Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882322 | Continuum Knee System (CKS) | Buckman Co., Inc. | 1989 | — |
| 0 (this device) | K981560 | Implex Continuum Knee System: Porous Tibial Component Model Number 05-230 System | Implex Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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? (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 |
|---|---|---|---|
| * | K882322 | Continuum Knee System (CKS)Summary page 2…iguration. The manufacturer name, device name, 510(k) number and 510(k) clearance date of the predicate devices are provided below: Implex Corp Continuum Knee System | K882322 2/8/89 Osteonics Series 7000 K940813 1/30/95 Smith & Nephew Genesis 11 K951987 8/22/95 Howmedica Duracon K926228 2/22/94 April 30… | 1989 |
| * | K940813 | Osteonics (R) Series 7000 Total KneeSummary page 2…vice name, 510(k) number and 510(k) clearance date of the predicate devices are provided below: Implex Corp Continuum Knee System | K882322 2/8/89 Osteonics Series 7000 K940813 1/30/95 Smith & Nephew Genesis 11 K951987 8/22/95 Howmedica Duracon K926228 2/22/94 April 30, 1998 Page - 52 - 510(k) Premarket… | 1995 |
| * | K951987 | Genesis II Total Knee SystemSummary page 2…nce date of the predicate devices are provided below: Implex Corp Continuum Knee System | K882322 2/8/89 Osteonics Series 7000 K940813 1/30/95 Smith & Nephew Genesis 11 K951987 8/22/95 Howmedica Duracon K926228 2/22/94 April 30, 1998 Page - 52 - 510(k) Premarket Notification Implex CK Porous Tibial Comp… | 1995 |
| * | K926228 | Duracon Cruciform Tibial BaseplateSummary page 2…are provided below: Implex Corp Continuum Knee System | K882322 2/8/89 Osteonics Series 7000 K940813 1/30/95 Smith & Nephew Genesis 11 K951987 8/22/95 Howmedica Duracon K926228 2/22/94 April 30, 1998 Page - 52 - 510(k) Premarket Notification Implex CK Porous Tibial Component Public Healt… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K882322.
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 Continum Knee System (CKS):Porous Tibial Component is intended for use in the total kee joint where severe degenration, trauma, or pathology of the knee indicates cemented total knee arthroplasty. The CKS is indicated for: a) Total Knee Replacement in severely disabled joints as a result of degenerative arthritis; b) Secondary revision of a previously unsuccessful tibial component; c) Other knee problems where clinical experience has shown that…
Read the full statement (112 words)
The Continum Knee System (CKS):Porous Tibial Component is intended for use in the total kee joint where severe degenration, trauma, or pathology of the knee indicates cemented total knee arthroplasty. The CKS is indicated for:
a) Total Knee Replacement in severely disabled joints as a result of degenerative arthritis;
b) Secondary revision of a previously unsuccessful tibial component;
c) Other knee problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results;
d) Trauma, or other fractures in which adequate bony fixation cannot be obtained;
e) Non-union of the proximal tibia; and
f) 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/K981560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981560: Implex Continuum Knee System: Porous Tibial Component Model Number 05-230 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981560
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