510(k) · Cleared
Recalled · Class II · 2013HG Multilock Hip Prosthesis W/ TI-Nidium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 22, 1994 after a 705-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 473 devices in its family, counting itself, has a Class I recall. 472 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 1994
- Review
- 705 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 0
472 later devices descend from it, 3 citing it directly. 1 of the 473 devices in this family, counting this one, has a Class I recall.
- This deviceK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994
- Descendant · cites it directly · 363 of its ownK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- Descendant · cites it directly · 309 of its ownK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 296 of its ownK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · 2 generations on · 213 of its ownK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
Showing 5 of 472 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…4 generations on · 2007
Most influential descendants
Showing 5 of 472 · See all- K964769Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997 · cites it directly363descendants
- K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 1998 · cites it directly309descendants
- K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · 2 generations on296descendants
- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 3 generations on267descendants
- K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000 · 2 generations on213descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | — |
| +1 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| +1 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| +2 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| +3 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +2 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 1 |
| 2008 | 12 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 19 | 0 |
| 2012 | 33 | 0 |
| 2013 | 31 | 0 |
| 2014 | 15 | 0 |
| 2015 | 18 | 0 |
| 2016 | 23 | 0 |
| 2017 | 29 | 0 |
| 2018 | 26 | 0 |
| 2019 | 35 | 0 |
| 2020 | 30 | 0 |
| 2021 | 24 | 0 |
| 2022 | 24 | 0 |
| 2023 | 23 | 0 |
| 2024 | 22 | 0 |
| 2025 | 32 | 0 |
| 2026 | 24 | 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.
1 device in this family has a Class I recall. 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (472)
See all 4723 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2013 | Class II | Z-1026-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K964769 (Zimmer, Inc., 1997) has gone furthest, with 363 descendants of its own.
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 | — |
https://510kreport.com/device/K921308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921308: HG Multilock Hip Prosthesis W/ TI-Nidium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921308
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026