510(k) · Cleared
ClearedCS2 Multi-Hole Acetabular Shell
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consensus Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 19, 2014 as substantially equivalent to K922561 (U.S. Medical Products, Inc., 1993) and 1 other predicate after a 26-day review. Its family tree reaches back 6 generations to 1993. 21 later devices descend from it.
- Decided
- May 19, 2014
- Review
- 26 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930712 (1993). 15 ancestors in all, the oldest K922561 (1993). 21 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 5 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 4 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 3 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 2 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 1 generation backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- This deviceK141043 CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc. · 2014
- Descendant · cites it directly · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · 2 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · 2 generations on · 7 of its ownK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- Descendant · 3 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- Descendant · 3 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · cites it directly19descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 2 generations on9descendants
- K172501iNSitu Total Hip SystemTheken Companies, LLC · 2017 · 2 generations on7descendants
- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 3 generations on5descendants
- K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −5 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −4 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −3 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −1 | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| 0 (this device) | K141043 | CS2 Multi-Hole Acetabular Shell | Consensus Orthopedics, Inc. | 2014 | — |
| +1 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +2 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +2 | K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017 | — |
| +3 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +3 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K922561 | Consensus (TM) Total Hip SystemSummary page 3…Trade Name 510(k) holder 510(k) Clearance Number Date K922561 ConsensUSTm Total Hip System Consensus Orthopedics, Inc. 07/21/1993 K060635 Consensus Acetabular Shell Sys… | 1993 |
| * | K060635 | Consensus Acetabular Shell SystemSummary page 3…Date K922561 ConsensUSTm Total Hip System Consensus Orthopedics, Inc. 07/21/1993 K060635 Consensus Acetabular Shell System Consensus Orthopedics, Inc. 04/28/2006 Legally Marketed Devices which are compa… | 2006 |
What descends from it? (21)
See all 212 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?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K161184 (Theken Companies, LLC, 2016) has gone furthest, with 19 descendants of its own.
- 10 other devices also cite its predicate K922561.
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. 2014, 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?
The C52Th Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, C52Th HIP SYSTEM, and the TAPERSET h HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS®D HIP SYSTEM. The indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic…
Read the full statement (260 words)
The C52Th Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, C52Th HIP SYSTEM, and the TAPERSET h HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS®D HIP SYSTEM.
The indications for use are:
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C. Proximal femoral fractures.
D. Avascular necrosis of the fermoral head.
E. Non-union of proximal femoral neck fractures.
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumiorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2Th and TAPERSETmu hip stems are indicated for cementless use.
The UNISYN"' HIP SYSTEM is indicated for significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
A. Proximal fermoral fractures.
B. Avascular necrosis of the femoral head.
C. Non-union of proximal femoral neck fractures.
D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vats, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
UNISYN' stems used with roughened and plasma coated bodies are intended for cemented or unceniented use. UNISYN" stems used with plasma/HA or HA coated bodies ame intended for uncemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141043: CS2 Multi-Hole Acetabular Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141043
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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