510(k) · Cleared
ClearedTaperset Hip Small Stems
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 Sep 10, 2012 as substantially equivalent to K102399 (Consensus Orthopedics, Inc., 2010) and 1 other predicate after a 70-day review. Its family tree reaches back 7 generations to 1993. 20 later devices descend from it.
- Decided
- Sep 10, 2012
- Review
- 70 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930712 (1993). 80 ancestors in all, the oldest K810258 (1981). 20 later devices descend from it, 1 citing it directly.
- 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 deviceK121935 Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012
- 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 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · 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 |
|---|---|---|---|---|---|
| −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) | K121935 | Taperset Hip Small Stems | Consensus Orthopedics, Inc. | 2012 | — |
| +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 |
|---|---|---|
| 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 | 2 | 0 |
| 2011 | 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 |
| 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 |
|---|---|---|---|
| * | K102399 | Consensus Taperset Hip SystemSummary page 2…ally equivalent to the legally marketed predicates. Non-Clinical Performance Data: The TaperSet small stems are identical to the predicate TaperSet stems cleared under K102399 in design, materials, packaging, and indications, the two new stems (5 & 6 mm) are just smaller in overall dimensions and thus cr… | 2010 |
| * | K103755 | Taperloc Complete, Size 5 and 6Summary page 2…orous coating, and indications as the predicate TaperSet stems cleared under KI 02399. Taper style femoral stems in sizes 5Sand 6mmn were previously cleared by FDA under K103755 for the Biomet Taperloc Complete Hip System extension. The subject Consensus stemns are still compatible with previously cleared… | 2011 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161184 | iNSitu Total Hip System | 2016 | 19 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 9 of the 80 ancestors have a recall of any class.
- Of its descendants, K161184 (Theken Companies, LLC, 2016) has gone furthest, with 19 descendants of its own.
- 6 other devices also cite its predicate K102399.
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. 2012, 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 TaperSetTM Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. 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…
Read the full statement (108 words)
The TaperSetTM Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.
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 TM hip stem is indicated for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121935: Taperset Hip Small Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121935
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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