510(k) · Cleared
ClearedCardo Medical Ceramic Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardo Medical, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on May 18, 2010 as substantially equivalent to K073068 (Accelerated Innovation, LLC, 2008) and 2 other predicates after a 134-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- May 18, 2010
- Review
- 134 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K931641 (1994). 27 ancestors in all, the oldest K862234 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 4 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 3 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 2 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 1 generation backK094045 Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp. · 2010
- This deviceK100008 Cardo Medical Ceramic Hip SystemCardo Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −5 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −4 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −3 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −2 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −1 | K094045 | Modificaiton to: Cardo Medical Hip System | Cardo Medical Corp. | 2010 | — |
| 0 (this device) | 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 |
| 2004 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K073068 | Accin Hip SystemSummary page 1…nted or non-porous, uncemented, 21 CFR 888.3353 Class 11 Predicate Device: Accin Tm Hip System (now Cardo Medical Hip System) - K073068, K094045 Stelkast 32mm Modular Ceramic Head - K033944 Device Description: The previously… | 2008 |
| * | K094045 | Modificaiton to: Cardo Medical Hip System Cleared while this submission was under review Summary page 1…non-porous, uncemented, 21 CFR 888.3353 Class 11 Predicate Device: Accin Tm Hip System (now Cardo Medical Hip System) - K073068, K094045 Stelkast 32mm Modular Ceramic Head - K033944 Device Description: The previously cleared… | 2010 |
| * | K033944 | Stelkast 32MM Modular Ceramic Femoral HeadSummary page 1…11 Predicate Device: Accin Tm Hip System (now Cardo Medical Hip System) - K073068, K094045 Stelkast 32mm Modular Ceramic Head - K033944 Device Description: The previously cleared Cardo Medical Hip System consists of * commer… | 2004 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 27 ancestors have a recall of any class.
- 2 other devices also cite its predicate K073068.
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. 2010, 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 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, osteoiarthritis, 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 with or without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100008 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100008: Cardo Medical Ceramic 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/K100008
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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