510(k) · Cleared
ClearedRadiographic Markers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Aug 22, 2001 as substantially equivalent to K010348 (Biomet, Inc., 2001) after a 70-day review. Its family tree reaches back 1 generation to 2001. 17 later devices descend from it.
- Decided
- Aug 22, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010348 (2001). 17 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK010348 Tantalum Beads - Radiographic MarkerBiomet, Inc. · 2001
- This deviceK011856 Radiographic MarkersEncore Orthopedics, Inc. · 2001
- Descendant · cites it directly · 16 of its ownK061066 Synergy Hip SystemSmith & Nephew, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK111546 U2 Hip SystemUnited Orthopedic Corp. · 2011 · Recalled
- Descendant · 3 generations on · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- Descendant · 4 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
- Descendant · 4 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K061066Synergy Hip SystemSmith & Nephew, Inc. · 2006 · cites it directly16descendants
- K111546U2 Hip SystemUnited Orthopedic Corp. · 2011 · 2 generations on13descendants
- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · 3 generations on7descendants
- K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 4 generations on3descendants
- K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010348 | Tantalum Beads - Radiographic Marker | Biomet, Inc. | 2001 | — |
| 0 (this device) | K011856 | Radiographic Markers | Encore Orthopedics, Inc. | 2001 | — |
| +1 | K061066 | Synergy Hip System | Smith & Nephew, Inc. | 2006 | — |
| +2 | K111546 | U2 Hip System | United Orthopedic Corp. | 2011 | 1 |
| +3 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| +4 | K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017 | — |
| +4 | K132455 | U-Motion II PS+ Cup | United Orthopedic Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 NEU? 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 NEU device
- #1 K240042 MOLLI 2 Systemscore 14.4 · 12 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 |
|---|---|---|---|
| * | K010348 | Tantalum Beads - Radiographic MarkerSummary page 1…ement. Comparable Features to Predicate Device(s): Features comparable to predicate devices include same materials, design and indications as the Biomet Tantalum Beads (K010348). & HiALny umicy, % ] {é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service % Food and Drug Administr… | 2001 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061066 | Synergy Hip System | 2006 | 16 |
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?
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, 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 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Radiographic Markers are intended for implantation in the bone to aid the surgeon in radiographic assessment of total hip or knee component movement. The Radiographic Markers are manufactured from inert, biocompatible materials.
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/K011856 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011856: Radiographic Markers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011856
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026