510(k) · Cleared
ClearedAnatomic Bone Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Double Medical Technology, Inc. · HRS Plate, Fixation, Bone
Cleared on Jan 18, 2023 as substantially equivalent to K130108 (Xiamen Double Engine Medical Material Co., Ltd., 2013) after a 280-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Jan 18, 2023
- Review
- 280 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983495 (1998). 8 ancestors in all, the oldest K963192 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
- 2 generations backK092889 Syntec Osteo-Plate and Screw FixationSyntec Scientific Corp. · 2010
- 1 generation backK130108 Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd. · 2013
- This deviceK221088 Anatomic Bone PlateDouble Medical Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK242348 Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242348Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S… | Syntec Scientific Corp. | 1998 | — |
| −2 | K092889 | Syntec Osteo-Plate and Screw Fixation | Syntec Scientific Corp. | 2010 | — |
| −1 | K130108 | Double Engine Bone Plate and Screw Systems | Xiamen Double Engine Medical Material Co., Ltd. | 2013 | — |
| 0 (this device) | K221088 | Anatomic Bone Plate | Double Medical Technology, Inc. | 2023 | — |
| +1 | K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K130108 | Double Engine Bone Plate and Screw SystemsSummary page 4…ulatory class II Classification panel Orthopedic 3. Predicate Device Legally marketed Predicate device: device(s) to which K130108 Double Engine Bone Plate and Bone Screw System equivalence is claimed Reason for 510(k) New device… | 2013 |
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 |
|---|---|---|---|
| K242348 | Locking Screw,CoCrMo | 2024 | 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 25 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K242348 (Double Medical Technology, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K130108.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral) of the clavicle, pelvis…
Read the full statement (155 words)
The Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral) of the clavicle, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities. Additional plates included in the system with specific indications as follows:
VAL (Variable Angle Locking) Distal Clavicle Plate is indicated for fractures of the shaft and lateral clavicle, malunions and non-unions ;
VAL Distal Humeral Plate is indicated for fractures (including supracondylar), and nonunions ;
VAL Distal Femoral Plate is indicated for distal femoral fractures (diaphyseal, supracondylar, and intra-articular);
Pelvic Bone Plate is indicated for pelvic fractures (e.g., acetabular , iliac wing, and symphysis pubis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221088: Anatomic Bone Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221088
Report an extraction error
Are you the manufacturer?
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