510(k) · Cleared
ClearedParagon Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Manufacturing Technology · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 14, 2013 as substantially equivalent to K042992 (DePuy Orthopaedics, Inc., 2005) and 2 other predicates after a 94-day review. Its family tree reaches back 8 generations to 1993. 2 later devices descend from it.
- Decided
- Mar 14, 2013
- Review
- 94 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K930712 (1993). 96 ancestors in all, the oldest K810258 (1981). 2 later devices descend 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 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 backK122512 CS2 Hip SystemConsensus Orthopedics, Inc. · 2012
- This deviceK123782 Paragon Hip SystemGlobal Manufacturing Technology · 2013
- Descendant · cites it directly · 1 of its ownK142201 OMNI Interface Acetabular SystemOmnlife Science · 2015
- Descendant · 2 generations on · 0 of its ownK171156 OMNI Anseris Hip StemOmnilife Science · 2017
Most influential descendants
Showing 2 of 2 · See allView 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 | K122512 | CS2 Hip System | Consensus Orthopedics, Inc. | 2012 | — |
| 0 (this device) | K123782 | Paragon Hip System | Global Manufacturing Technology | 2013 | — |
| +1 | K142201 | OMNI Interface Acetabular System | Omnlife Science | 2015 | — |
| +2 | K171156 | OMNI Anseris Hip Stem | Omnilife Science | 2017 | — |
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 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 16 | 0 |
| 1995 | 7 | 0 |
| 1996 | 15 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K042992 | Corail Amt Hip ProsthesisSummary page 2…information presented in the 510(k) supports the substantial equivalence of the Paragonrm Hip System to the following predicate devices: DePuy Orthopaedics Corail Hip (K(042992), Smith & Nephew's Anthology Hip (K(052792), and Consensus CS2TM Hip System (1(122512). Substantial Equivalence: The components… | 2005 |
| * | K052792 | Anthology Hip StemSummary page 2…s the substantial equivalence of the Paragonrm Hip System to the following predicate devices: DePuy Orthopaedics Corail Hip (K(042992), Smith & Nephew's Anthology Hip (K(052792), and Consensus CS2TM Hip System (1(122512). Substantial Equivalence: The components of the ParagonTm Hip System are substantial… | 2005 |
| * | K122512 | CS2 Hip SystemSummary page 2…nrm Hip System to the following predicate devices: DePuy Orthopaedics Corail Hip (K(042992), Smith & Nephew's Anthology Hip (K(052792), and Consensus CS2TM Hip System (1(122512). Substantial Equivalence: The components of the ParagonTm Hip System are substantially equivalent to the identified predicates… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142201 | OMNI Interface Acetabular System | 2015 | 1 |
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 20 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 11 of the 96 ancestors have a recall of any class.
- Of its descendants, K142201 (Omnlife Science, 2015) has gone furthest, with 1 descendant of its own.
- 26 other devices also cite its predicate K042992.
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. 2013, 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?
The Paragon"" Hip System is intended for use as the femoral component of a total hip replacement or partial hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: 1. Degenerative osteoarthritis of the hip. 2. Inflammatory arthritis of the hip. 3. Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral…
Read the full statement (141 words)
The Paragon"" Hip System is intended for use as the femoral component of a total hip replacement or partial hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
1. Degenerative osteoarthritis of the hip.
2. Inflammatory arthritis of the hip.
3. Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip).
4. Displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse.
5. Avascular Necrosis of the femoral head.
6- Revision of a failed femoral component from previous hip surgery e.g. internal fixation device from previous osteotomy, fracture treatment or hemi-arthroptasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123782 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123782: Paragon Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123782
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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