510(k) · Cleared
ClearedPremier-Total Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Aug 28, 1989 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Aug 28, 1989
- Review
- 82 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK894051 Premier-Total HipIntermedics Orthopedics · 1989
- Descendant · cites it directly · 6 of its ownK960258 Natural Hip SystemIntermedics Orthopedics · 1996
- Descendant · 2 generations on · 5 of its ownK172857 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018
- Descendant · 3 generations on · 3 of its ownK180973 Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK253171 Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK222436 Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K960258Natural Hip SystemIntermedics Orthopedics · 1996 · cites it directly6descendants
- K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018 · 2 generations on5descendants
- K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018 · 3 generations on3descendants
- K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026 · 4 generations on0descendants
- K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894051 | Premier-Total Hip | Intermedics Orthopedics | 1989 | — |
| +1 | K960258 | Natural Hip System | Intermedics Orthopedics | 1996 | — |
| +2 | K172857 | Latitud Hip Replacement System | Meril Healthcare Pvt., Ltd. | 2018 | — |
| +3 | K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | 2018 | — |
| +4 | K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026 | — |
| +3 | K222436 | Latitud™ Hip Replacement System | Meril Healthcare Pvt., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 LWJ? 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? (8)
2 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, K960258 (Intermedics Orthopedics, 1996) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K894051 · printed Nov 5, 2026
Cite this page
510(k) Report. “K894051: Premier-Total Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894051
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026