510(k) · Cleared
ClearedTaperSet™ Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 20, 2025 as substantially equivalent to K141043 (Consensus Orthopedics, Inc., 2014) and 1 other predicate after a 73-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Nov 20, 2025
- Review
- 73 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930712 (1993). 79 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 6 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 5 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 4 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 2 generations backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- 1 generation backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- This deviceK252846 TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −6 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −5 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −4 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −2 | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| −1 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| 0 (this device) | K252846 | TaperSet™ Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 13 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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 24.3 · 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 |
|---|---|---|---|
| * | K141043 | CS2 Multi-Hole Acetabular ShellSummary page 5….3358 (primary), 888.3353, 888.3350 Product Code(s): LPH (Primary), LZO, JDI, OQG, OQI Legally Marketed Predicate Devices (21 CFR 807.92(a)(3)) Primary Predicate #: K141043 Additional Predicate #: K102399 510(k… | 2014 |
| * | K102399 | Consensus Taperset Hip SystemSummary page 4…onsensus all-poly acetabular cup is intended for cemented use. The intended use or indications for use of the TaperSet™ Hip System are similar to its original clearance K102399 except the removal of ‘partial hip arthroplasty” as the DAA surgical technique is only applicable to the total hip system. Typ… | 2010 |
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?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 9 of the 79 ancestors have a recall of any class.
- 1 other device also cites its predicate K141043.
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. 2025, 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 indications for use for TaperSet™ Hip System are: The TaperSet™ Hip System is designed for total hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System including the CS2™ Acetabular Cup 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.…
Read the full statement (198 words)
The indications for use for TaperSet™ Hip System are:
The TaperSet™ Hip System is designed for total hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System including the CS2™ Acetabular Cup 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 femoral 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 tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The TaperSet™ hip stem is indicated for cementless use.
The Consensus acetabular cup components are intended for cemented or cementless use. The CS2 Ti plasma coated acetabular shell is intended for cementless use. The Consensus all-poly acetabular cup is intended for cemented use.
The intended use or indications for use of the TaperSet™ Hip System are similar to its original clearance K102399 except the removal of ‘partial hip arthroplasty” as the DAA surgical technique is only applicable to the total hip system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252846 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252846: TaperSet™ Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252846
Report an extraction error
Are you the manufacturer?
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