510(k) · Cleared
Recalled · 2010Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HRS Plate, Fixation, Bone
Cleared on Dec 10, 2003 as substantially equivalent to K993106 (Smith & Nephew, Inc., 1999) and 4 other predicates after a 19-day review. Its family tree reaches back 2 generations to 1998. 1 of the 699 devices in its family, counting itself, has a Class I recall. 690 later devices descend from it. It has been recalled once.
- Decided
- Dec 10, 2003
- Review
- 19 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 2 generations to K981372 (1998). 8 ancestors in all. 690 later devices descend from it, 28 citing it directly. 1 of the 699 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 1 generation backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- This deviceK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003
- Descendant · cites it directly · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · cites it directly · 501 of its ownK062216 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · cites it directly · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 258 of its ownK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
Showing 5 of 690 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 690 · See all- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · cites it directly584descendants
- K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · cites it directly501descendants
- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · cites it directly495descendants
- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · cites it directly487descendants
- K050457Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005 · cites it directly258descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −1 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| 0 (this device) | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | — |
| +1 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +1 | K062216 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2006 | 1 |
| +1 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| +1 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +1 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 11 | 0 |
| 2011 | 14 | 0 |
| 2012 | 20 | 0 |
| 2013 | 25 | 0 |
| 2014 | 36 | 0 |
| 2015 | 39 | 0 |
| 2016 | 30 | 0 |
| 2017 | 51 | 0 |
| 2018 | 30 | 0 |
| 2019 | 36 | 0 |
| 2020 | 41 | 0 |
| 2021 | 47 | 1 |
| 2022 | 40 | 0 |
| 2023 | 50 | 0 |
| 2024 | 65 | 0 |
| 2025 | 59 | 0 |
| 2026 | 73 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 1…HRS and HWC / Orthopedics / 87 Device Description: The Smith & Nephew Locking Bone Plate System is a modification of the Smith & Nephew Bone Plate System cleared under K993106. Like the predicate devices listed below, components include various sizes of contoured and straight, locking bone plates, lockin… | 1999 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…overall indications for use, and material composition. * Smith & Nephew Bone Plate System - K993106 · Synthes Small Fragment Locking Compression Plate (LCP) - K000684 · Synthes Locking Calcaneal Plate - K991407 * Synthes LCP for the Distal Femur - K000066 * Synthes LCP for the Pro… | 2000 |
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 1…tion. * Smith & Nephew Bone Plate System - K993106 · Synthes Small Fragment Locking Compression Plate (LCP) - K000684 · Synthes Locking Calcaneal Plate - K991407 * Synthes LCP for the Distal Femur - K000066 * Synthes LCP for the Proximal Tibiat - K011978 DEPART… | 1999 |
| * | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) SystemSummary page 1…993106 · Synthes Small Fragment Locking Compression Plate (LCP) - K000684 · Synthes Locking Calcaneal Plate - K991407 * Synthes LCP for the Distal Femur - K000066 * Synthes LCP for the Proximal Tibiat - K011978 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2000 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 1…ion Plate (LCP) - K000684 · Synthes Locking Calcaneal Plate - K991407 * Synthes LCP for the Distal Femur - K000066 * Synthes LCP for the Proximal Tibiat - K011978 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2001 |
What descends from it? (690)
See all 69028 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | 2005 | 584 |
| K062216 | Peri-Loc Periarticular Locked Plating System | 2006 | 501 |
| K071563 | Peri-Loc Periarticular Locked Plating System | 2007 | 495 |
| K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | 2009 | 487 |
| K050457 | Merete Metafix Small Fragment Bone Plate System | 2005 | 258 |
| K063487 | Merete BLP Small Fragment Locking Bone Plate | 2007 | 257 |
| K081513 | Merete 3.0 and 3.5 MM Locking Screws | 2008 | 256 |
| K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications | 2008 | 186 |
| K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | 2006 | 108 |
| K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access | 2007 | 93 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2010 | Not classified | Z-2314-2010 | Packaging | Inner packaging of sterile product was not sealed. Lack of sterility assurance. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K051735 (Smith & Nephew, Inc., 2005) has gone furthest, with 584 descendants of its own.
- 35 other devices also cite its predicate K993106.
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 Smith & Nephew Locking Bone Plate System is used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones (particularly in osteopenic bone); treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
Components in the Smith & Nephew Locking Bone Plate System are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033669
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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