510(k) · Cleared
ClearedOmni Arc Monoblock Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnilife Science · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 13, 2014 as substantially equivalent to K113242 (Omni Life Science, Inc., 2012) and 1 other predicate after a 129-day review. Its family tree reaches back 13 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 13, 2014
- Review
- 129 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K941847 (1994). 122 ancestors in all, the oldest K810258 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations between
- 3 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 2 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 1 generation backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- This deviceK133381 Omni Arc Monoblock Hip StemOmnilife Science · 2014
- Descendant · cites it directly · 0 of its ownK172467 OMNI ARC Anteverted Neck Hip StemOmnilife Science · 2017
- Descendant · cites it directly · 0 of its ownK171156 OMNI Anseris Hip StemOmnilife Science · 2017
Show all 13 generations
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 11 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 10 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 9 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 8 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 7 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 6 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 5 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 4 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 3 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 2 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 1 generation backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- This deviceK133381 Omni Arc Monoblock Hip StemOmnilife Science · 2014
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 |
|---|---|---|---|---|---|
| −13 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −12 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −11 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −10 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −9 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −8 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −7 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −6 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −5 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −4 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −3 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −2 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −1 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| 0 (this device) | K133381 | Omni Arc Monoblock Hip Stem | Omnilife Science | 2014 | — |
| +1 | K172467 | OMNI ARC Anteverted Neck Hip Stem | Omnilife Science | 2017 | — |
| +1 | K171156 | OMNI Anseris Hip Stem | Omnilife Science | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 15 | 0 |
| 1995 | 12 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 4 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K113242 | Apex Arc Hip StemSummary page 1…cemented or nonporous uncemented prosthesis. LZ0, MEH, LPH, KWY K1 13242 - Apex Hip System ARC' m Hip Stem (c/eared size 0)… | 2012 |
| * | K110947 | Apex K1 Hip StemSummary page 1…K1 13242 - Apex Hip System ARC' m Hip Stem (c/eared size 0) K1 10947 - Apex K1 Tm Hip Stem Predicate Device Reference predicates:… | 2011 |
| † | K111193 | Apex Arc Hip Stem | 2011 |
| † | K060072 | Monoblock Press-Fit Hip Stem | 2006 |
What descends from it? (2)
2 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 20 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 34 of the 121 ancestors have a recall of any class.
- Of its descendants, K172467 (Omnilife Science, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K113242.
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. 2014, 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 OMNI ARC Monoblock Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex lnterfaceTM' Acetabular System. The Apex InterfaceM Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following…
Read the full statement (202 words)
The OMNI ARC Monoblock Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex lnterfaceTM' Acetabular System. The Apex InterfaceM Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate:
*Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
* Rheumatoid arthritis;
* Correction of functional deformity;
* Congenital dislocation;
* Revision procedures where other treatments or devices have failed;
* Femoral neck and trochanteric fractures of the proximal femur.
The OMNI ARC Monoblock Hip Stem is also intended for use in hemniarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemniarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
* Femoral neck and trochanteric fractures of the proximal femur;
* Osteonecrosis of the femoral head;
* Revision procedures where other treatments or devices for these indications have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133381: Omni Arc Monoblock 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/K133381
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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