510(k) · Cleared
ClearedThe Trabecular Metal Monoblock Cup, Models 00-7259-0XX-28 (Zimmer Cat. #) and 02-293-28XX1 (Implex Part #)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implex Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 12, 2002 as substantially equivalent to K964509 (Implex Corp., 1997) and 1 other predicate after a 25-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jul 12, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964509 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964509 Implex a-240 Hep Acetabular Cup SystemImplex Corp. · 1997 · Recalled
- This deviceK021970 The Trabecular Metal Monoblock Cup, Models 00-7259-0XX-28 (Zimmer…Implex Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964509 | Implex a-240 Hep Acetabular Cup System | Implex Corp. | 1997 | 1 |
| 0 (this device) | K021970 | The Trabecular Metal Monoblock Cup, Models 00-7259-0XX-28 (Zimmer Cat. #) and… | Implex Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K964509 | Implex a-240 Hep Acetabular Cup SystemSummary page 1…utilizes the same instrumentation and surgical protocol as the Hedrocel and Trabecular Metal Monoblock Cups (K964509 and KO03181>. These acetabular devices are intended for use with Zimmer and lmplex Components as… | 1997 |
| * | K003181 | Implex Continuum Hip System Acetabular Components - Model XX-Yyy-ZZZZ | 2000 |
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 2 ancestors has a recall of any class.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The use of the Implex Hip System is indicated for:
a) Severely disabled joints as a result of degenerative arthritis or avascular necrosis,
b) Secondary revision of a previously unsuccessful femoral component or total hip replacement,
c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results,
d) Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be achieved,
e) Non-union or femoral neck or head fractures,
f) Salvage of a failed primary or secondary total or hemi hip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021970: The Trabecular Metal Monoblock Cup, Models 00-7259-0XX-28 (Zimmer Cat. #) and 02-293-28XX1 (Implex Part #).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021970
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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