510(k) · Cleared
ClearedModificaiton to: Cardo Medical Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardo Medical Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 22, 2010 as substantially equivalent to K073068 (Accelerated Innovation, LLC, 2008) and 2 other predicates after a 112-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Apr 22, 2010
- Review
- 112 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K931641 (1994). 25 ancestors in all, the oldest K862234 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 4 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 3 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 2 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 1 generation backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- This deviceK094045 Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp. · 2010
- Descendant · cites it directly · 0 of its ownK100008 Cardo Medical Ceramic Hip SystemCardo Medical, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K100008Cardo Medical Ceramic Hip SystemCardo Medical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −4 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −3 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −2 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −1 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| 0 (this device) | K094045 | Modificaiton to: Cardo Medical Hip System | Cardo Medical Corp. | 2010 | — |
| +1 | K100008 | Cardo Medical Ceramic Hip System | Cardo Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 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? (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 |
|---|---|---|---|
| * | K073068 | Accin Hip SystemSummary page 1…constrained uncemented prosthesis, 21 CFR 888.3358 Class 1I Predicate Devices: Accinm Hip System (now Cardo Medical Hip System) - K073068 Exactech 12114 Total Hip System (Exactech, Inc.) - K(041906, K993082 Device Description: T… | 2008 |
| * | K041906 | Exactech 12/14 Total Hip SystemSummary page 1…Predicate Devices: Accinm Hip System (now Cardo Medical Hip System) - K073068 Exactech 12114 Total Hip System (Exactech, Inc.) - K(041906, K993082 Device Description: The previously cleared Cardo Medical Hip System consists of… | 2004 |
| * | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentSummary page 1…e Devices: Accinm Hip System (now Cardo Medical Hip System) - K073068 Exactech 12114 Total Hip System (Exactech, Inc.) - K(041906, K993082 Device Description: The previously cleared Cardo Medical Hip System consists of *commerci… | 1999 |
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 |
|---|---|---|---|
| K100008 | Cardo Medical Ceramic Hip System | 2010 | 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 16 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K100008 (Cardo Medical, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K073068.
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. 2010, 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 Cardo Medical Hip System components are for use in total hip arthroplasty as a result of:
* Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip
* Correction of functional deformity
* Avascular Necrosis
* Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur
* Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results
These components are single use only and are intended for implantation without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K094045: Modificaiton to: Cardo Medical Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094045
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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