510(k) · Cleared
ClearedBIOLOX delta Option and Extra-long Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 6, 2018 as substantially equivalent to K130376 (Wrightmedicaltechnologyinc, 2013) and 1 other predicate after a 206-day review. Its family tree reaches back 2 generations to 2008. 2 later devices descend from it.
- Decided
- Jul 6, 2018
- Review
- 206 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K072656 (2008). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK072656 Dynasty Ceramic Femoral HeadWrightmedicaltechnologyinc · 2008
- 1 generation backK130376 Dynasty Acetabular System with CeramicWrightmedicaltechnologyinc · 2013
- This deviceK173776 BIOLOX delta Option and Extra-long HeadsMicroport Orthopedics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK240046 Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024
- Descendant · cites it directly · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
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 |
|---|---|---|---|---|---|
| −2 | K072656 | Dynasty Ceramic Femoral Head | Wrightmedicaltechnologyinc | 2008 | — |
| −1 | K130376 | Dynasty Acetabular System with Ceramic | Wrightmedicaltechnologyinc | 2013 | — |
| 0 (this device) | K173776 | BIOLOX delta Option and Extra-long Heads | Microport Orthopedics, Inc. | 2018 | — |
| +1 | K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | 2024 | — |
| +1 | K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K130376 | Dynasty Acetabular System with CeramicSummary page 4…Class II Subject Product Code and Panel Code: Orthopedics/87/LZO Predicate Device: Femoral Head: K130376 DYNASTY® Acetabular System with Ceramic Neck Sleeve:… | 2013 |
| * | K072656 | Dynasty Ceramic Femoral HeadSummary page 4…K130376 DYNASTY® Acetabular System with Ceramic Neck Sleeve: K072656 DYNASTY® Acetabular System Reference Device: Femoral Head: K14… | 2008 |
| † | K140043 | Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head | 2014 |
| † | K953025 | SLT 28MM XXL Femoral Head | 1995 |
| † | K141653 | Biolox Delta Ceramic Option Heads | 2014 |
| † | K131684 | Biolox (R) Delta Ceramic Heads | 2013 |
| † | K131518 | Mectacer Biolox Option Heads | 2013 |
| † | K112115 | Mectacer Biolox (R) Delta Femoral Heads | 2011 |
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 10 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240046 (Microport Orthopedics, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K130376.
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. 2018, 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?
MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173776: BIOLOX delta Option and Extra-long Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173776
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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