510(k) · Cleared
ClearedPROCOTYL® PRIME Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 26, 2017 as substantially equivalent to K002149 (Wrightmedicaltechnologyinc, 2000) and 8 other predicates after a 132-day review. Its family tree reaches back 6 generations to 1993. 16 later devices descend from it.
- Decided
- Jun 26, 2017
- Review
- 132 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K930712 (1993). 19 ancestors in all, the oldest K864626 (1986). 16 later devices descend from it, 8 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 backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- 1 generation backK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- This deviceK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
- Descendant · cites it directly · 10 of its ownK171181 PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017
- Descendant · 2 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
- Descendant · cites it directly · 2 of its ownK180798 Prime Acetabular Cup SystemMicroport Orthopedics, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK240834 EcoFit® short stem cementless cpTiImplantcast GmbH · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017 · cites it directly10descendants
- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 2 generations on5descendants
- K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 3 generations on4descendants
- K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc. · 2018 · cites it directly2descendants
- K240834EcoFit® short stem cementless cpTiImplantcast GmbH · 2024 · 3 generations on1descendant
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 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| −1 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| 0 (this device) | K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | 2017 | — |
| +1 | K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | Microport Orthopedics, Inc. | 2017 | — |
| +2 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +3 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
| +1 | K180798 | Prime Acetabular Cup System | Microport Orthopedics, Inc. | 2018 | — |
| +3 | K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 2 | 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? (9)
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 |
|---|---|---|---|
| * | K002149 | Lineage Acetabular SystemSummary page 4…fixation fastener - Class II Subject Product Code and Panel Orthopedics/87/LPH, LZO, HWC Code: Predicate Device: LINEAGE® Acetabular System (K002149 – Shell) LINEAGE® Acetabular System (K052026 - Liner) Can… | 2000 |
| * | K052026 | Lineage a-Class Poly LinerSummary page 4…s/87/LPH, LZO, HWC Code: Predicate Device: LINEAGE® Acetabular System (K002149 – Shell) LINEAGE® Acetabular System (K052026 - Liner) Cancellous Bone Screw (K864626) DYNASTY® Acetab… | 2005 |
| * | K864626 | Cancellous Bone ScrewSummary page 4…ular System (K002149 – Shell) LINEAGE® Acetabular System (K052026 - Liner) Cancellous Bone Screw (K864626) DYNASTY® Acetabular System (K082924 Shells; K002149, K0… | 1986 |
| * | K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal…Summary page 4…Acetabular System (K052026 - Liner) Cancellous Bone Screw (K864626) DYNASTY® Acetabular System (K082924 Shells; K002149, K061547, K070785, K082924 Liners) Zimme… | 2009 |
| * | K061547 | Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular LinerSummary page 4…Cancellous Bone Screw (K864626) DYNASTY® Acetabular System (K082924 Shells; K002149, K061547, K070785, K082924 Liners) Zimmer Biomet Trilogy Acetabular Cup System… | 2006 |
| * | K070785 | Dynasty Acetabular SystemSummary page 4…Cancellous Bone Screw (K864626) DYNASTY® Acetabular System (K082924 Shells; K002149, K061547, K070785, K082924 Liners) Zimmer Biomet Trilogy Acetabular Cup System… | 2007 |
| * | K934765 | Trilogy Acetabular SystemSummary page 4…K002149, K061547, K070785, K082924 Liners) Zimmer Biomet Trilogy Acetabular Cup System (K934765, K953490) Depuy Pinnacle 100 Shell (K090998)… | 1994 |
| * | K953490 | Trilogy Acetabular Shell & Liners 36MMSummary page 4…K002149, K061547, K070785, K082924 Liners) Zimmer Biomet Trilogy Acetabular Cup System (K934765, K953490) Depuy Pinnacle 100 Shell (K090998)… | 1995 |
| * | K090998 | Depuy Pinnacle 100 with Gription Acetabular CupsSummary page 4…Zimmer Biomet Trilogy Acetabular Cup System (K934765, K953490) Depuy Pinnacle 100 Shell (K090998) 1… | 2009 |
What descends from it? (16)
See all 168 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | 2017 | 10 |
| K180798 | Prime Acetabular Cup System | 2018 | 2 |
| K190123 | MicroPort CoCr Femoral Heads | 2019 | 1 |
| K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | 2018 | 1 |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | 2024 | 0 |
| K213816 | MPO Hip Instruments | 2022 | 0 |
| K201157 | Prime BIOFOAM® Multi-Hole Shells | 2021 | 0 |
| K202705 | Prime and DYNASTY® Additive Manufacturing Shells | 2021 | 0 |
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 24 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K171181 (Microport Orthopedics, Inc., 2017) has gone furthest, with 10 descendants of its own.
- 10 other devices also cite its predicate K002149.
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. 2017, 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 PROCOTYL® PRIME Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2) inflammatory degenerative joint disease such as rheumatoid arthritis;
3) correction of functional deformity; and,
4) revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170444: PROCOTYL® PRIME Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170444
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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