510(k) · Cleared
ClearedPrime 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 Sep 14, 2018 as substantially equivalent to K171181 (Microport Orthopedics, Inc., 2017) and 1 other predicate after an 88-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it.
- Decided
- Sep 14, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K930712 (1993). 22 ancestors in all, the oldest K864626 (1986). 1 later device descends from it, 1 citing it directly.
- 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 backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- 3 generations backK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 2 generations backK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
- 1 generation backK171181 PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017
- This deviceK181598 Prime E-CLASS XLPE LinerMicroport Orthopedics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK240046 Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024
Most influential descendants
Showing 1 of 1 · See all- K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024 · cites it directly0descendants
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 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| −3 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −2 | K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | 2017 | — |
| −1 | K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | Microport Orthopedics, Inc. | 2017 | — |
| 0 (this device) | K181598 | Prime E-CLASS XLPE Liner | Microport Orthopedics, Inc. | 2018 | — |
| +1 | K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | 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 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K171181 | PROCOTYL® PRIME E-CLASS™ XLPE LinerSummary page 4…H, OQG, OQI Predicate Devices: PROCOTYL® PRIME E-CLASS™ XLPE Liner (K171181) Prime Acetabular Cup System XLPE Liner… | 2017 |
| * | K180798 | Prime Acetabular Cup System Cleared while this submission was under review Summary page 4…(K171181) Prime Acetabular Cup System XLPE Liner (K180798) MicroPort Orthopedics Inc. MicroPort Orthopedics BV 5677 Airline Road, Arlington, TN USA 38002 Hoogoordd… | 2018 |
| † | K170444 | PROCOTYL® PRIME Acetabular Cup System | 2017 |
| † | K002149 | Lineage Acetabular System | 2000 |
| † | K052026 | Lineage a-Class Poly Liner | 2005 |
| † | K061547 | Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular Liner | 2006 |
| † | K070785 | Dynasty Acetabular System | 2007 |
| † | K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | 2024 | 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 25 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K240046 (Microport Orthopedics, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K171181.
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. 2018, 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?
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/K181598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181598: 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/K181598
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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