510(k) · Cleared
ClearedCeramic Ball Heads, 28, 32 and 36 MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics AG · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 1, 2007 as substantially equivalent to K061564 (Portland Orthopaedics Pty., Ltd., 2006) after a 120-day review. Its family tree reaches back 1 generation to 2006. 18 later devices descend from it.
- Decided
- Aug 1, 2007
- Review
- 120 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061564 (2006). 18 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK061564 Portland Ceramic (Biolox-Forte) Femoral HeadPortland Orthopaedics Pty., Ltd. · 2006
- This deviceK070928 Ceramic Ball Heads, 28, 32 and 36 MMPlus Orthopedics AG · 2007
- Descendant · cites it directly · 16 of its ownK073337 Mectacer Biolox Forte-Femoral HeadsMedacta International S.A. · 2008
- Descendant · 2 generations on · 14 of its ownK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
- Descendant · 2 generations on · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
- Descendant · 3 generations on · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · 4 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K073337Mectacer Biolox Forte-Femoral HeadsMedacta International S.A. · 2008 · cites it directly16descendants
- K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011 · 2 generations on14descendants
- K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · 2 generations on8descendants
- K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · 3 generations on7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061564 | Portland Ceramic (Biolox-Forte) Femoral Head | Portland Orthopaedics Pty., Ltd. | 2006 | — |
| 0 (this device) | K070928 | Ceramic Ball Heads, 28, 32 and 36 MM | Plus Orthopedics AG | 2007 | — |
| +1 | K073337 | Mectacer Biolox Forte-Femoral Heads | Medacta International S.A. | 2008 | — |
| +2 | K112115 | Mectacer Biolox (R) Delta Femoral Heads | Medacta International | 2011 | — |
| +2 | K121665 | Bencox Foret & Bencox Delta | Corentec Co., Ltd. | 2012 | — |
| +3 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +4 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K061564 | Portland Ceramic (Biolox-Forte) Femoral HeadSummary page 1…emented or Nonporous Uncemented Prosthesis, Title 21 CFR Part 888.3353 4.0 Substantial Equivalence Claimed to Predicate Device Portland Ceramic (BIOLOX®forte), K061564 5.0 Device Description The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip… | 2006 |
What descends from it? (18)
See all 182 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?
- Its one ancestor has no recall.
- Of its descendants, K073337 (Medacta International S.A., 2008) has gone furthest, with 16 descendants of its own.
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. 2007, 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 Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's…
Read the full statement (223 words)
The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's condition should be due to the following:
1. Osteoarthritis
2. Rheumatoid arthritis
3. Tumor conditions involving the upper third of the femur of the Acetabular
4. Ankylosing spondylitis
5. Psoriatic arthritis
6. Old osteomyelitis - with a long infection-free period and a normal WBC. ESR and C-reactive protein
7. Non-union of femoral neck fracture or avascular necrosis of the femoral head
8. Post-traumatic fracture/dislocation of the hip
9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present
11. Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty.
These ceramic ball heads are to be used only hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR- PLUS®, SL- PLUS® Lateral, Modular- PLUS® and IPM stem.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070928: Ceramic Ball Heads, 28, 32 and 36 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070928
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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