510(k) · Cleared
ClearedPeri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access
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 Nov 19, 2007 as substantially equivalent to K993289 (Smith & Nephew, Inc., 1999) and 3 other predicates after a 48-day review. Its family tree reaches back 3 generations to 1998. 93 later devices descend from it.
- Decided
- Nov 19, 2007
- Review
- 48 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K981372 (1998). 16 ancestors in all, the oldest K903810 (1990). 93 later devices descend from it, 10 citing it directly.
- Root · 3 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 2 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 1 generation backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- This deviceK072818 Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe…Smith & Nephew, Inc. · 2007
- Descendant · cites it directly · 77 of its ownK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 46 of its ownK132886 Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · cites it directly · 38 of its ownK100325 Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010
- Descendant · cites it directly · 35 of its ownK080434 Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008
- Descendant · 2 generations on · 34 of its ownK090656 Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · cites it directly77descendants
- K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on46descendants
- K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010 · cites it directly38descendants
- K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008 · cites it directly35descendants
- K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −2 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −1 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| 0 (this device) | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access | Smith & Nephew, Inc. | 2007 | — |
| +1 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| +2 | K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +1 | K100325 | Peri-Loc Locking Hole Inserts and Cable Accessories | Smith & Nephew, Inc. | 2010 | — |
| +1 | K080434 | Intertan CHS Locking Plate System Prox Fem Plates/Screw | Smith & Nephew, Inc. | 2008 | — |
| +2 | K090656 | Intertan CHS Limited Collapse Set Screw | Smith & Nephew, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 13 | 0 |
| 2024 | 14 | 0 |
| 2025 | 11 | 0 |
| 2026 | 6 | 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? (4)
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 |
|---|---|---|---|
| * | K993289 | Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw SystemSummary page 1…ased on similarities in design features, overall indications for use, and material composition. * Smith &Nephew Bone Plate System (TC-100 Plating System) Blade Plates- K993289 * PERI-LOC TM Periarticular Locked Plating System - K033669 * Smith & Nephew 6.5mm and 8.0mm Cannulated Screws - K060736 *… | 1999 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 1…ng System - Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are line additions to the PERI-LOC TM Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various lengths of contoured locking bone plates and loc… | 2003 |
| * | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSummary page 1…System (TC-100 Plating System) Blade Plates- K993289 * PERI-LOC TM Periarticular Locked Plating System - K033669 * Smith & Nephew 6.5mm and 8.0mm Cannulated Screws - K060736 * Synthes (USA) LCP Proximal Femur Plate and Screws - K030858 Premarket Notifica… | 2006 |
| * | K030858 | Synthes (Usa) LCP Proximal Femur Plate and ScrewsSummary page 1…C TM Periarticular Locked Plating System - K033669 * Smith & Nephew 6.5mm and 8.0mm Cannulated Screws - K060736 * Synthes (USA) LCP Proximal Femur Plate and Screws - K030858 Premarket Notification Indications for Use Statement… | 2003 |
What descends from it? (93)
See all 9310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083032 | Peri-Loc Bone Plating and Screw System | 2009 | 77 |
| K100325 | Peri-Loc Locking Hole Inserts and Cable Accessories | 2010 | 38 |
| K080434 | Intertan CHS Locking Plate System Prox Fem Plates/Screw | 2008 | 35 |
| K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | 2013 | 33 |
| K210837 | Smith & Nephew Plates and Screws | 2021 | 7 |
| K201918 | EVOS Large Fragment Plating System | 2020 | 4 |
| K203405 | EVOS Large Fragment Plating System | 2021 | 3 |
| K112406 | Peri-Loc Proximal Femur Locking Bone Plates | 2011 | 3 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP… | 2022 | 2 |
| K181640 | X-BOLT Hip Fracture Fixation System | 2018 | 1 |
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 9 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K083032 (Smith & Nephew, Inc., 2009) has gone furthest, with 77 descendants of its own.
- 12 other devices also cite its predicate K993289.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
PERI-LOCTM Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOCTM Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multifragmentary, and fractures with…
Read the full statement (126 words)
PERI-LOCTM Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOCTM Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multifragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
Components in the PERI-LOCTM Periarticular Locked Plating System - Proximal Femur Bone Plates and Bone Screws are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072818 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072818: Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072818
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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