510(k) · Cleared
ClearedB-Bop Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · HRS Plate, Fixation, Bone
Cleared on Sep 13, 2005 as substantially equivalent to K040907 (Arthrex, Inc., 2004) and 2 other predicates after a 36-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Sep 13, 2005
- Review
- 36 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K000684 (2000). 13 ancestors in all, the oldest K890939 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 4 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 3 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 2 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 1 generation backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- This deviceK052152 B-Bop PlateNew Deal, S.A. · 2005
- Descendant · cites it directly · 0 of its ownK063831 Basal Dorsal PlatesNewdeal Sas · 2007
Most influential descendants
Showing 1 of 1 · See all- K063831Basal Dorsal PlatesNewdeal Sas · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −4 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −3 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −2 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −1 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| 0 (this device) | K052152 | B-Bop Plate | New Deal, S.A. | 2005 | — |
| +1 | K063831 | Basal Dorsal Plates | Newdeal Sas | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K040907 | Arthrex Small Fragment Plates and ScrewsSummary page 2…in terms of design, material, indications for use and fixation with the following predicate devices: Arthrex Small Fragment Plates and Screws K040907 Acumed Congruent Bone Plate System K012655 Synthes Modular Foot System… | 2004 |
| * | K012655 | Congruent Bone Plate SystemSummary page 2…ith the following predicate devices: Arthrex Small Fragment Plates and Screws K040907 Acumed Congruent Bone Plate System K012655 Synthes Modular Foot System K001941 H. Comparison of Technological Characteristics Th… | 2001 |
| * | K001941 | Synthes Modular Foot SystemSummary page 2…gment Plates and Screws K040907 Acumed Congruent Bone Plate System K012655 Synthes Modular Foot System K001941 H. Comparison of Technological Characteristics The technological characteristics of the B-BOP plate are the same as the… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063831 | Basal Dorsal Plates | 2007 | 0 |
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 4 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K063831 (Newdeal Sas, 2007) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K040907.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The B-BOP® plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include:
- Moderate to severe hallux valgus
- Hallux varus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052152: B-Bop Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052152
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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