510(k) · Cleared
ClearedXerxes Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xerxes Arthopedix, LLC · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jun 15, 2023 as substantially equivalent to K170845 (Medacta International S.A., 2017) and 5 other predicates after a 57-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Jun 15, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K930712 (1993). 128 ancestors in all, the oldest K830313 (1983). No later device cites it as a predicate yet.
- Root · 9 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 5 generations between
- 3 generations backK093646 Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 2 generations backK121297 Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 2012 · Recalled
- 1 generation backK153131 Logical C-Series Acetabular Shell, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016
- This deviceK231109 Xerxes Hip StemXerxes Arthopedix, LLC · 2023
Show all 9 generations
- Root · 9 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 8 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 7 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 6 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 5 generations backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- 4 generations backK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 3 generations backK093646 Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 2 generations backK121297 Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 2012 · Recalled
- 1 generation backK153131 Logical C-Series Acetabular Shell, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016
- This deviceK231109 Xerxes Hip StemXerxes Arthopedix, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −8 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −7 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −6 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| −4 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −3 | K093646 | Depuy Pinnacle with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −2 | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal… | Signature Orthopaedics Pty, Ltd. | 2012 | 2 |
| −1 | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical… | Signature Orthopaedics Pty, Ltd. | 2016 | — |
| 0 (this device) | K231109 | Xerxes Hip Stem | Xerxes Arthopedix, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 17 | 0 |
| 1995 | 11 | 0 |
| 1996 | 14 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K170845 | MiniMAXSummary page 4…prosthesis Product Codes: LZO, MEH, KWZ Predicate Devices: Primary Predicate • Medacta International’s MiniMAX Stem (K170845 & K192352) Additional Predicate Device(s):… | 2017 |
| * | K192352 | MiniMAXSummary page 4…MEH, KWZ Predicate Devices: Primary Predicate • Medacta International’s MiniMAX Stem (K170845 & K192352) Additional Predicate Device(s): • Signature Orthopaedics’ Spartan Hip S… | 2019 |
| * | K192883 | Spartan Hip StemSummary page 4…K192352) Additional Predicate Device(s): • Signature Orthopaedics’ Spartan Hip Stem (K192883) • Signature Orthopaedics’ Everglade Hip Stem (K211505) • Signature O… | 2020 |
| * | K211505 | Encore Hip StemSummary page 4…Device(s): • Signature Orthopaedics’ Spartan Hip Stem (K192883) • Signature Orthopaedics’ Everglade Hip Stem (K211505) • Signature Orthopaedics’ OriginTM Total Hip System (K121297)… | 2021 |
| * | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Summary page 4…Signature Orthopaedics’ Everglade Hip Stem (K211505) • Signature Orthopaedics’ OriginTM Total Hip System (K121297) • Signature Orthopaedics’ Logical C-Series Acetabular Shell, Log… | 2012 |
| * | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Summary page 4…ll, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20º Hooded Acetabular Liner (K153131) Device Description: XerxesTM Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F13… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 28 of the 127 ancestors have a recall of any class.
- 3 other devices also cite its predicate K170845.
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. 2023, 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?
Xerxes Hip Stems, when used with cleared and compatible Signature Orthopaedics hip replacement components, are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: - Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - Inflammatory joint disease including rheumatoid…
Read the full statement (171 words)
Xerxes Hip Stems, when used with cleared and compatible Signature Orthopaedics hip replacement components, are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
- Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- Inflammatory joint disease including rheumatoid arthritis
- Correction of functional deformity including congenital hip dysplasia
- Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement.
Xerxes Hip femoral stems are intended for cementless fixation only. The Xerxes Hip System is intended for use with Logical, World Acetabular System and Signature Orthopaedics' Femoral Heads.
Xerxes Hip when used with constrained liner components is indicated particularly for patients at high risk of hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231109: Xerxes Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231109
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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