510(k) · Cleared
ClearedZimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
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 May 31, 2019 as substantially equivalent to K063251 (Zimmer, Inc., 2007) and 2 other predicates after a 247-day review. Its family tree reaches back 8 generations to 1985. 1 of the 22 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 31, 2019
- Review
- 247 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K850055 (1985). 20 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 7 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 6 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 5 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 4 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 3 generations backK042337 Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 2004
- 2 generations backK063251 Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc. · 2007 · Recalled
- 1 generation backK071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System…Zimmer, Inc. · 2007 · Recalled (Class I)
- This deviceK182678 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK200959 Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR…Biomet UK, Ltd. · 2020
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…direct predicate · 2007
Most influential descendants
Showing 1 of 1 · See all- K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −7 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −6 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −5 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −4 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −3 | K042337 | Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 2004 | — |
| −2 | K063251 | Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology | Zimmer, Inc. | 2007 | 4 |
| −1 | K071856 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S)… | Zimmer, Inc. | 2007 | Class I |
| 0 (this device) | K182678 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling | Zimmer, Inc. | 2019 | — |
| +1 | K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | Biomet UK, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K063251 | Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologySummary page 4…Calcium Phosphate (21 CFR 888.3353) Predicate Device(s): Zimmer, Inc. K063251 Zimmer M/L Taper Hip Prosthesis With Modular Neck Technology… | 2007 |
| * | K071856 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Summary page 4…K063251 Zimmer M/L Taper Hip Prosthesis With Modular Neck Technology K071856 Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology System, Model(S) 7848… | 2007 |
| * | K081007 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemSummary page 4…Kinectiv Technology System, Model(S) 7848 Series( Modular Necks), 7713 Series K081007 Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology System… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | 2020 | 0 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 9 of the 20 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200959 (Biomet UK, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K063251.
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. 2019, this device’s year, is highlighted.
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?
• Total hip replacement for patients with: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. • Hemi-hip replacement for…
Read the full statement (135 words)
• Total hip replacement for patients with:
severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
• Hemi-hip replacement for patients with:
fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
• The femoral stem is for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182678: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182678
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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