510(k) · Cleared
ClearedBRM TOOL Screws, BIOPLAN Subtalar Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brm Extremities · HWC Screw, Fixation, Bone
Cleared on Dec 16, 2022 as substantially equivalent to K203773 (Brm Extremities Srl, 2022) and 1 other predicate after an 88-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Dec 16, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K962616 (1996). 224 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- 2 generations backK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
- 1 generation backK203773 BRM TOOL ScrewsBrm Extremities Srl · 2022
- This deviceK222820 BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 4 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 3 generations backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- 2 generations backK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
- 1 generation backK203773 BRM TOOL ScrewsBrm Extremities Srl · 2022
- This deviceK222820 BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −4 | K142442 | Magna-FX and Mini Magna-FX Cannulated Screw Fixation System | Zimmer, Inc. | 2014 | 3 |
| −3 | K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015 | — |
| −2 | K163489 | OrthoSolutions 'System26' Bone Screws | Ortho Solutions UK Limited | 2017 | 1 |
| −1 | K203773 | BRM TOOL Screws | Brm Extremities Srl | 2022 | — |
| 0 (this device) | K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | Brm Extremities | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 19 | 0 |
| 1997 | 3 | 0 |
| 1998 | 8 | 0 |
| 1999 | 10 | 0 |
| 2000 | 14 | 0 |
| 2001 | 12 | 0 |
| 2002 | 12 | 0 |
| 2003 | 11 | 0 |
| 2004 | 8 | 0 |
| 2005 | 19 | 0 |
| 2006 | 14 | 0 |
| 2007 | 9 | 0 |
| 2008 | 7 | 0 |
| 2009 | 8 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K203773 | BRM TOOL ScrewsSummary page 5…and PEEK options. Predicate Devices and Technological Comparison: The BRM Screw Family of devices are substantially equivalent to the primary predicate BRM TOOL Screws (K203773) and additional predicate In2Bone PIT’Stop Subtalar Implant (K170688) with respect to intended use, indications for use, design a… | 2022 |
| * | K170688 | PIT’Stop® implantSummary page 5…e BRM Screw Family of devices are substantially equivalent to the primary predicate BRM TOOL Screws (K203773) and additional predicate In2Bone PIT’Stop Subtalar Implant (K170688) with respect to intended use, indications for use, design and materials (Titanium Alloy and PEEK). Performance Testing: Testing… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 37 of the 224 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion, and bone fragment fixation appropriate with the size of the screw. The BIOPLAN Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive…
Read the full statement (120 words)
The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion, and bone fragment fixation appropriate with the size of the screw.
The BIOPLAN Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
• Flat foot treatment in children and adolescents
• Congenital flat foot
• Non successful long term orthopaedic treatment (shoes, insoles ...)
• Tarsal coalitions
• Painfully flat foot
• Supple deformity in posterior tibial tendon dysfunction
• Paralytic flat foot
• Subtalar instability
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222820 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222820: BRM TOOL Screws, BIOPLAN Subtalar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222820
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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