510(k) · Cleared
ClearedUltima TPS Cemented Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson International · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Jul 23, 1997 as substantially equivalent to K891454 (Howmedica Corp., 1989) after a 209-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jul 23, 1997
- Review
- 209 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891454 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891454 Exeter II Total Hip SystemHowmedica Corp. · 1989
- This deviceK965198 Ultima TPS Cemented StemJohnson & Johnson International · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891454 | Exeter II Total Hip System | Howmedica Corp. | 1989 | — |
| 0 (this device) | K965198 | Ultima TPS Cemented Stem | Johnson & Johnson International | 1997 | — |
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 KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K891454 | Exeter II Total Hip SystemSummary page 1…ubstantial Equivalence The safety and effectiveness of the ULTIMA* TPS Cemented Stemyis substantially equivalent in terms of function to the Howmedica Exeter hip stem (#K891454) and to the Zimmer CPT hip stem. Furthermore, testing results demonstrate that the ULTIMA™ TPS Cemented Stem is substantially equ… | 1989 |
| * | — | Zimmer CPT hip stem Named without a submission number |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K891454.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | 2 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The ULTIMA* TPS Cemented Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to:
structural damage in the hip joint from rheumatoid arthritis,
osteoarthritis,
post-traumatic arthritis,
collagen disorders,
avascular necrosis,
nonunion of femoral fractures,
congenital hip dysplasia,
protrusio acetabuli,
slipped capital femoral epiphysis, and
disability due to previous fusion where bone stock is inadequate for other reconstruction techniques.
The ULTIMA* TPS Cemented Stem is indicated for use only with PMMA bone cement.
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/K965198 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965198: Ultima TPS Cemented Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965198
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