510(k) · Cleared
ClearedProcotyl L-O Acetabular 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 Feb 27, 2015 as substantially equivalent to K002149 (Wrightmedicaltechnologyinc, 2000) and 3 other predicates after a 207-day review. Its family tree reaches back 3 generations to 2008. 9 later devices descend from it.
- Decided
- Feb 27, 2015
- Review
- 207 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K072656 (2008). 5 ancestors in all, the oldest K002149 (2000). 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK072656 Dynasty Ceramic Femoral HeadWrightmedicaltechnologyinc · 2008
- 2 generations backK130376 Dynasty Acetabular System with CeramicWrightmedicaltechnologyinc · 2013
- 1 generation backK140043 Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta…Microport Orthopedics, Inc. · 2014
- This deviceK142119 Procotyl L-O Acetabular SystemMicroport Orthopedics, Inc. · 2015
- 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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 |
|---|---|---|---|---|---|
| −3 | K072656 | Dynasty Ceramic Femoral Head | Wrightmedicaltechnologyinc | 2008 | — |
| −2 | K130376 | Dynasty Acetabular System with Ceramic | Wrightmedicaltechnologyinc | 2013 | — |
| −1 | K140043 | Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head | Microport Orthopedics, Inc. | 2014 | — |
| 0 (this device) | K142119 | Procotyl L-O Acetabular System | Microport Orthopedics, Inc. | 2015 | — |
| +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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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 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? (4)
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…Class II Subject Product Code and Panel Code: Orthopedics/87/LPH/LZO Predicate Devices: LINEAGE™ Acetabular System (K002149 shells; K052026 liners) DYNA… | 2000 |
| * | K052026 | Lineage a-Class Poly LinerSummary page 4…Orthopedics/87/LPH/LZO Predicate Devices: LINEAGE™ Acetabular System (K002149 shells; K052026 liners) DYNASTY® Acetabular System (K130376… | 2005 |
| * | K130376 | Dynasty Acetabular System with CeramicSummary page 4…System (K002149 shells; K052026 liners) DYNASTY® Acetabular System (K130376 28mm heads; K140043 32-36mm heads)… | 2013 |
| * | K140043 | Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral HeadSummary page 4…lls; K052026 liners) DYNASTY® Acetabular System (K130376 28mm heads; K140043 32-36mm heads) 1 === Page 5 ==… | 2014 |
What descends from it? (9)
3 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 7 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K180263 (Implantcast GmbH, 2018) has gone furthest, with 5 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. 2015, 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® L-O Acetabular 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…
Read the full statement (99 words)
The PROCOTYL® L-O Acetabular 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
The PROCOTYL® L-O Acetabular System utilizes single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142119: Procotyl L-O Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142119
Report an extraction error
Are you the manufacturer?
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