510(k) · Cleared
ClearedZirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the Encore Vitality Stems and SL and
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jun 27, 1997 as substantially equivalent to K944601 (Zimmer, Inc., 1995) and 2 other predicates after a 193-day review. Its family tree reaches back 2 generations to 1983. 10 later devices descend from it.
- Decided
- Jun 27, 1997
- Review
- 193 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K823727 (1983). 15 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK823727 Spectron Primary Stem Femoral ProsthesRichard'S Medical Equip., Inc. · 1983
- 1 generation backK935921 Zirconia Ceramic Femoral HeadSmith & Nephew Richards, Inc. · 1994
- This deviceK965002 Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and…Encore Orthopedics, Inc. · 1997
- Descendant · cites it directly · 9 of its ownK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
- Descendant · 2 generations on · 7 of its ownK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
- Descendant · 3 generations on · 4 of its ownK101451 Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010
- Descendant · 4 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 5 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999 · cites it directly9descendants
- K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001 · 2 generations on7descendants
- K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010 · 3 generations on4descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 4 generations on2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K823727 | Spectron Primary Stem Femoral Prosthes | Richard'S Medical Equip., Inc. | 1983 | — |
| −1 | K935921 | Zirconia Ceramic Femoral Head | Smith & Nephew Richards, Inc. | 1994 | — |
| 0 (this device) | K965002 | Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous… | Encore Orthopedics, Inc. | 1997 | — |
| +1 | K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | Plus Orthopedics | 1999 | — |
| +2 | K012918 | Apex Modular Alumina Femoral Head | Apex Surgical, LLC | 2001 | — |
| +3 | K101451 | Apex Module Hip System Biolox Delta Femoral Head | Omni Life Science, Inc. | 2010 | — |
| +4 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +5 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K944601 | Zimmer Zirconia Ceramic Femoral HeadSummary page 1…itality™ Stem and SL and SLR PLUS Hip Stems are equivalent in material, design and clinical indications to the zirconia heads also manufactured by Demarquest for Zimmer (K944601) , DuPuy (K926395), and Smith and Nephew Richards, Inc. (K935921). Public Health Service Food and Drug Administr… | 1995 |
| * | K926395 | Elite (TM) Zirconia Total Hip Ball Head SystemSummary page 1…SL and SLR PLUS Hip Stems are equivalent in material, design and clinical indications to the zirconia heads also manufactured by Demarquest for Zimmer (K944601) , DuPuy (K926395), and Smith and Nephew Richards, Inc. (K935921). Public Health Service Food and Drug Administration DEPARTMENT… | 1994 |
| * | K935921 | Zirconia Ceramic Femoral HeadSummary page 1…erial, design and clinical indications to the zirconia heads also manufactured by Demarquest for Zimmer (K944601) , DuPuy (K926395), and Smith and Nephew Richards, Inc. (K935921). Public Health Service Food and Drug Administration DEPARTMENT OF HEALTH & HUMAN SERVICES 9200 Corporate Boule… | 1994 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | 1999 | 9 |
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 14 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K990261 (Plus Orthopedics, 1999) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K944601.
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.
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 indications for use of the total hip replacement prosthesis include:
noninflammatory degenerative joint disease including osteoarthritis and
avascular necrosis; rheumatoid arthritis; correction of functional deformity;
revision procedures where other treatments or devices have failed; and
treatment of nonunion, femoral neck and trochanteric fractures of the
proximal femur with head involvement, which is unmanageable using other
techniques.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965002: Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the Encore Vitality Stems and SL and.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965002
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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