510(k) · Cleared
ClearedSynergy Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 14, 2006 as substantially equivalent to K963509 (Smith & Nephew Richards, Inc., 1997) and 6 other predicates after an 88-day review. Its family tree reaches back 2 generations to 2001. 16 later devices descend from it.
- Decided
- Jul 14, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K010348 (2001). 7 ancestors in all, the oldest K963509 (1997). 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK010348 Tantalum Beads - Radiographic MarkerBiomet, Inc. · 2001
- 1 generation backK011856 Radiographic MarkersEncore Orthopedics, Inc. · 2001
- This deviceK061066 Synergy Hip SystemSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 13 of its ownK111546 U2 Hip SystemUnited Orthopedic Corp. · 2011 · Recalled
- Descendant · 2 generations on · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- Descendant · 3 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
- Descendant · 3 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
- Descendant · 2 generations on · 3 of its ownK122504 Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K111546U2 Hip SystemUnited Orthopedic Corp. · 2011 · cites it directly13descendants
- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · 2 generations on7descendants
- K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 3 generations on3descendants
- K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 3 generations on3descendants
- K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010348 | Tantalum Beads - Radiographic Marker | Biomet, Inc. | 2001 | — |
| −1 | K011856 | Radiographic Markers | Encore Orthopedics, Inc. | 2001 | — |
| 0 (this device) | K061066 | Synergy Hip System | Smith & Nephew, Inc. | 2006 | — |
| +1 | K111546 | U2 Hip System | United Orthopedic Corp. | 2011 | 1 |
| +2 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| +3 | K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017 | — |
| +3 | K132455 | U-Motion II PS+ Cup | United Orthopedic Corp. | 2013 | — |
| +2 | K122504 | Femoral Heads, 2.5 and 7.5 MM Neck Length | United Orthopedic Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (7)
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 |
|---|---|---|---|
| * | K963509 | Global Taper Tapered Hip System, GT SpectronSummary page 2…tantial Equivalence The intended use, design, and materials of the Synergy Hip System are substantially equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509, K970337, K991485 and K002996), Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component IK002747), Biomet Tantalum Bea… | 1997 |
| * | K970337 | HA Global Taper (GT) Tapered Hip StemSummary page 2…quivalence The intended use, design, and materials of the Synergy Hip System are substantially equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509, K970337, K991485 and K002996), Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component IK002747), Biomet Tantalum Bead, Radiog… | 1997 |
| * | K991485 | Synergy Porous Size 8 Hip StemSummary page 2…e The intended use, design, and materials of the Synergy Hip System are substantially equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509, K970337, K991485 and K002996), Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component IK002747), Biomet Tantalum Bead, Radiographic Ma… | 1999 |
| * | K002996 | Synergy HA Coated Porous Femoral StemsSummary page 2…ed use, design, and materials of the Synergy Hip System are substantially equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509, K970337, K991485 and K002996), Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component IK002747), Biomet Tantalum Bead, Radiographic Marker (K01034… | 2000 |
| * | K002747 | Reflection Cross-Linked Uhmwpe Acetabular ComponentsSummary page 2…valent to the Smith & Nephew Synergy Global Taper Hip System (K963509, K970337, K991485 and K002996), Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component IK002747), Biomet Tantalum Bead, Radiographic Marker (K010348)and Encore Orthopedics Radiographic Marker (K011856). 4t… | 2000 |
| * | K010348 | Tantalum Beads - Radiographic MarkerSummary page 2…System (K963509, K970337, K991485 and K002996), Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component IK002747), Biomet Tantalum Bead, Radiographic Marker (K010348)and Encore Orthopedics Radiographic Marker (K011856). 4t DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2001 |
| * | K011856 | Radiographic MarkersSummary page 2…th & Nephew Reflection Cross-Linked UHMWPE Acetabular Component IK002747), Biomet Tantalum Bead, Radiographic Marker (K010348)and Encore Orthopedics Radiographic Marker (K011856). 4t DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2001 |
What descends from it? (16)
See all 162 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 5 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K111546 (United Orthopedic Corp., 2011) has gone furthest, with 13 descendants of its own.
- 10 other devices also cite its predicate K963509.
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 Synergy Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The Synergy Hip System is also…
Read the full statement (156 words)
The Synergy Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The Synergy Hip System is also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The Synergy Hip System is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061066: Synergy Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061066
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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