510(k) · Cleared
ClearedCoated ZT Proximal Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joint Medical Products Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 3, 1994 after a 266-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 378 devices in its family, counting itself, has a Class I recall. 377 later devices descend from it.
- Decided
- Jun 3, 1994
- Review
- 266 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
377 later devices descend from it, 6 citing it directly. 1 of the 378 devices in this family, counting this one, has a Class I recall.
- This deviceK934412 Coated ZT Proximal SleeveJoint Medical Products Corp. · 1994
- Descendant · cites it directly · 210 of its ownK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- Descendant · 2 generations on · 189 of its ownK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- Descendant · 3 generations on · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- Descendant · 4 generations on · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- Descendant · cites it directly · 168 of its ownK000788 Apex Modular Hip StemApex Surgical, LLC · 2000
Showing 5 of 377 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 377 · See all- K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996 · cites it directly210descendants
- K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998 · 2 generations on189descendants
- K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000 · 3 generations on188descendants
- K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · 4 generations on168descendants
- K000788Apex Modular Hip StemApex Surgical, LLC · 2000 · cites it directly168descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934412 | Coated ZT Proximal Sleeve | Joint Medical Products Corp. | 1994 | — |
| +1 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| +2 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| +3 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| +4 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| +1 | K000788 | Apex Modular Hip Stem | Apex Surgical, LLC | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 1 |
| 2008 | 8 | 0 |
| 2009 | 2 | 0 |
| 2010 | 10 | 0 |
| 2011 | 14 | 0 |
| 2012 | 18 | 0 |
| 2013 | 17 | 0 |
| 2014 | 12 | 0 |
| 2015 | 12 | 0 |
| 2016 | 16 | 0 |
| 2017 | 18 | 0 |
| 2018 | 17 | 0 |
| 2019 | 23 | 0 |
| 2020 | 23 | 0 |
| 2021 | 17 | 0 |
| 2022 | 26 | 0 |
| 2023 | 30 | 0 |
| 2024 | 25 | 0 |
| 2025 | 33 | 0 |
| 2026 | 30 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (377)
See all 3776 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | 1996 | 210 |
| K000788 | Apex Modular Hip Stem | 2000 | 168 |
| K994286 | ZMR Hip System-Porous Revision | 2000 | 105 |
| K042127 | Smith & Nephew Modular Hip | 2004 | 17 |
| K052426 | Smith & Nephew Modular Hip | 2005 | 6 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | 2024 | 5 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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, K961939 (Johnson & Johnson Professionals, Inc., 1996) has gone furthest, with 210 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/K934412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934412: Coated ZT Proximal Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934412
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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