510(k) · Cleared
ClearedKeYi Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Keyi Medical Device Technology Co., Ltd. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 14, 2020 as substantially equivalent to K111472 (Tgm Medical, 2011) and 4 other predicates after a 311-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- May 14, 2020
- Review
- 311 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K930712 (1993). 101 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 7 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 6 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 5 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 4 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 3 generations backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- 2 generations backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- 1 generation backK111472 Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head…Tgm Medical · 2011
- This deviceK191826 KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −7 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −6 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −5 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −3 | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| −2 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| −1 | K111472 | Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr… | Tgm Medical | 2011 | — |
| 0 (this device) | K191826 | KeYi Total Hip System | Beijing Keyi Medical Device Technology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 16 | 0 |
| 1995 | 8 | 0 |
| 1996 | 16 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 24.2 · 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? (5)
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 |
|---|---|---|---|
| * | K111472 | Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Summary page 4…-coated uncemented prosthesis Review Panel: Orthopedic Device Panel Predicate Devices: K111472 – HELICON Hip System Additional Predicate Device: K980513 –Depuy Articul/Eze femoral Heads… | 2011 |
| * | K980513 | Articul/Eze Femoral HeadsSummary page 4…Review Panel: Orthopedic Device Panel Predicate Devices: K111472 – HELICON Hip System Additional Predicate Device: K980513 –Depuy Articul/Eze femoral Heads K961186 –Depuy Duraloc Cementless Acetabular cup… | 1998 |
| * | K961186 | Depuy Duraloc Cementless Acetabular Cup SystemSummary page 4…es: K111472 – HELICON Hip System Additional Predicate Device: K980513 –Depuy Articul/Eze femoral Heads K961186 –Depuy Duraloc Cementless Acetabular cup system… | 1996 |
| * | K001991 | Titan Porocoat Hip ProsthesisSummary page 4…K961186 –Depuy Duraloc Cementless Acetabular cup system K001991 – DePuy Titan Porocoat Hip Stem K983491 – Depuy Duraloc Acetabular Cup System-… | 2000 |
| * | K983491 | Depuy Duraloc Acetabular Cup System-Enduron LinerSummary page 4…system K001991 – DePuy Titan Porocoat Hip Stem K983491 – Depuy Duraloc Acetabular Cup System- Enduron Liner Reason for 510(k) Submissio… | 1998 |
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 27 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 9 of the 101 ancestors have a recall of any class.
- 3 other devices also cite its predicate K111472.
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. 2020, 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 KeYi Total Hip System is designed for total hip arthroplasty. 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…
Read the full statement (108 words)
The KeYi Total Hip System is designed for total hip arthroplasty. 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 KeYi femoral stems are indicated for cementless use. The KeYi acetabular shells are indicated for cemented or cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191826: KeYi Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191826
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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