510(k) · Cleared
ClearedPeri-Loc Locking Hole Inserts and Cable Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HWC Screw, Fixation, Bone
Cleared on May 4, 2010 as substantially equivalent to K033669 (Smith & Nephew, Inc., 2003) and 4 other predicates after an 89-day review. Its family tree reaches back 9 generations to 1996. 38 later devices descend from it.
- Decided
- May 4, 2010
- Review
- 89 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K962616 (1996). 39 ancestors in all, the oldest K890939 (1989). 38 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 1 generation backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- This deviceK100325 Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010
- Descendant · cites it directly · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 2 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 13 of its ownK170887 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017
- Descendant · 2 generations on · 12 of its ownK173293 EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 1 generation backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- This deviceK100325 Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on32descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
- K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017 · cites it directly13descendants
- K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. · 2018 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −2 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −1 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| 0 (this device) | K100325 | Peri-Loc Locking Hole Inserts and Cable Accessories | Smith & Nephew, Inc. | 2010 | — |
| +1 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +2 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +3 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +1 | K170887 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | 2017 | — |
| +2 | K173293 | EVOS Small Fragment Upper Extremity Plates | Smith & Nephew, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 1…serts and Cable Accessories. The PERI-LOC Locking Hole Inserts and Cable Accessories are line additions to the PERI-LOC Periarticular Locked Plating System cleared under K033669, K051735, K061352, K(072818, and K(082516. The subject Locking Hole Inserts and Cable Saddles are accessory components that may b… | 2003 |
| * | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySummary page 1…Cable Accessories. The PERI-LOC Locking Hole Inserts and Cable Accessories are line additions to the PERI-LOC Periarticular Locked Plating System cleared under K033669, K051735, K061352, K(072818, and K(082516. The subject Locking Hole Inserts and Cable Saddles are accessory components that may be used in… | 2005 |
| * | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySummary page 1…cessories. The PERI-LOC Locking Hole Inserts and Cable Accessories are line additions to the PERI-LOC Periarticular Locked Plating System cleared under K033669, K051735, K061352, K(072818, and K(082516. The subject Locking Hole Inserts and Cable Saddles are accessory components that may be used in conjunct… | 2006 |
| * | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSummary page 2…icular Locked Plating System for the Upper Extremity - K061352 *PERI-LOC Periarticular Locked Plating System Proximal Femur Plates, Screws, and Cable Accessories - K072818 *PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws - K082516… | 2007 |
| * | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSummary page 2…icular Locked Plating System Proximal Femur Plates, Screws, and Cable Accessories - K072818 *PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws - K082516 Page 2of 2 DEPA… | 2008 |
What descends from it? (38)
See all 384 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 39 ancestors have a recall of any class.
- Of its descendants, K123055 (Smith & Nephew, Inc., 2013) has gone furthest, with 33 descendants of its own.
- 27 other devices also cite its predicate K033669.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below: The PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for fixation of pelvic, small and…
Read the full statement (212 words)
PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below:
The PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Locking Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, 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-LOC Periarticular Locked Plating System are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100325: Peri-Loc Locking Hole Inserts and Cable Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100325
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