510(k) · Cleared
ClearedPROCOTYL® PRIME E-CLASS™ XLPE Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 28, 2017 as substantially equivalent to K170444 (Microport Orthopedics, Inc., 2017) and 5 other predicates after a 126-day review. Its family tree reaches back 7 generations to 1993. 10 later devices descend from it.
- Decided
- Aug 28, 2017
- Review
- 126 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K930712 (1993). 20 ancestors in all, the oldest K864626 (1986). 10 later devices descend from it, 4 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 backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- 2 generations backK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 1 generation backK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
- This deviceK171181 PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- Descendant · 2 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- Descendant · 2 generations on · 1 of its ownK240834 EcoFit® short stem cementless cpTiImplantcast GmbH · 2024
- Descendant · 2 generations on · 1 of its ownK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
- Descendant · cites it directly · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · cites it directly5descendants
- K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 2 generations on4descendants
- K240834EcoFit® short stem cementless cpTiImplantcast GmbH · 2024 · 2 generations on1descendant
- K223103BethaLoc® stem cementless HAImplantcast GmbH · 2023 · 2 generations on1descendant
- K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
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 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| −2 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −1 | K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | 2017 | — |
| 0 (this device) | K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | Microport Orthopedics, Inc. | 2017 | — |
| +1 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +2 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
| +2 | K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024 | — |
| +2 | K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023 | — |
| +1 | K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018 | — |
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 |
|---|---|---|
| 2018 | 3 | 0 |
| 2021 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K170444 | PROCOTYL® PRIME Acetabular Cup System Cleared while this submission was under review Summary page 4…H/OQG/OQI Primary Predicate Device: PROCOTYL® PRIME Acetabular Cup System (K170444) LINEAGE® Acetabular System (K002149 and Additional Predicate Devices… | 2017 |
| * | K002149 | Lineage Acetabular SystemSummary page 4…Cup System (K170444) LINEAGE® Acetabular System (K002149 and Additional Predicate Devices: K052026)… | 2000 |
| * | K052026 | Lineage a-Class Poly LinerSummary page 4…LINEAGE® Acetabular System (K002149 and Additional Predicate Devices: K052026) DYNASTY® Acetabular System (K082924,… | 2005 |
| * | K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal…Summary page 4…K052026) DYNASTY® Acetabular System (K082924, K061547, and K070785) Reference Device:… | 2009 |
| * | K061547 | Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular LinerSummary page 4…DYNASTY® Acetabular System (K082924, K061547, and K070785) Reference Device: StelKast’s EXp Acetabular Liner (K094035, Models… | 2006 |
| * | K070785 | Dynasty Acetabular SystemSummary page 4…DYNASTY® Acetabular System (K082924, K061547, and K070785) Reference Device: StelKast’s EXp Acetabular Liner (K094035, Models… | 2007 |
| † | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM | 2011 |
What descends from it? (10)
4 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 24 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K180263 (Implantcast GmbH, 2018) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K170444.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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 · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
PROCOTYL® PRIME hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion 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/K171181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171181
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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