510(k) · Cleared

Cleared

PE.R.I. II Knee Fracture System

K003235510(k) TraditionalCleared Nov 6, 200020-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Nov 6, 2000 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 80 later devices descend from it.

Decided: Nov 6, 2000
Review: 20 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

80 later devices descend from it, 3 citing it directly.

This deviceK003235 PE.R.I. II Knee Fracture SystemDePuy Orthopaedics, Inc. · 2000
Descendant · cites it directly · 68 of its ownK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
Descendant · 2 generations on · 25 of its ownK061211 NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · Recalled
Descendant · 2 generations on · 21 of its ownK081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer…Zimmer GmbH · 2008 · Recalled
Descendant · 2 generations on · 20 of its ownK121672 Aft Proximal Humerus Fracture PlateShoulder Options, Inc. · 2012
Descendant · 2 generations on · 18 of its ownK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

2004high 7 (2017) · low 0 (2005)2026

Most influential descendants

Showing 5 of 80 · See all

K042695NCB Plating SystemZimmer GmbH · 2004 · cites it directly68descendants
K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · 2 generations on25descendants
K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Zimmer GmbH · 2008 · 2 generations on21descendants
K121672Aft Proximal Humerus Fracture PlateShoulder Options, Inc. · 2012 · 2 generations on20descendants
K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · 2 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003235	PE.R.I. II Knee Fracture System	DePuy Orthopaedics, Inc.	2000	—
+1	K042695	NCB Plating System	Zimmer GmbH	2004	1
+2	K061211	NCB Plating System, Proximal Tibia Plates	Zimmer GmbH	2006	4
+2	K081759	NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal…	Zimmer GmbH	2008	2
+2	K121672	Aft Proximal Humerus Fracture Plate	Shoulder Options, Inc.	2012	—
+2	K100111	NCB Periprosthetic Femur Polyaxial Locking Plate System	Zimmer, Inc.	2010	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	2	0
2007	1	0
2008	1	0
2010	3	0
2011	1	0
2012	4	0
2013	3	0
2014	2	0
2015	5	0
2016	6	0
2017	7	0
2018	7	0
2019	2	0
2020	4	0
2021	4	0
2022	2	0
2023	7	0
2024	7	0
2025	5	0
2026	6	0

FIG. 1 — Lineage of K003235, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (80)

See all 80

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042695	NCB Plating System	Zimmer GmbH	2004	68
K060969	Polyax Locked Plating System	DePuy Orthopaedics, Inc.	2006	10
K111663	Trauma Internal Fixation Systems	DePuy Orthopaedics, Inc.	2012	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?

Of its descendants, K042695 (Zimmer GmbH, 2004) has gone furthest, with 68 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)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	—

https://510kreport.com/device/K003235 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003235: PE.R.I. II Knee Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003235

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026