510(k) · Cleared

Cleared

Orthopedic Fixation Systems

K140216510(k) TraditionalCleared May 1, 201493-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

Impact Medical, LLC · HRS Plate, Fixation, Bone

Cleared on May 1, 2014 as substantially equivalent to K110086 (Internal Fixation Systems, Inc., 2011) and 6 other predicates after a 93-day review. Its family tree reaches back 7 generations to 1976.

Decided: May 1, 2014
Review: 93 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 7

Its longest line of descent runs back 7 generations to K761228 (1976). 72 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 7 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
6 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
5 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
4 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
3 generations backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
2 generations backK063589 Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007
1 generation backK071035 Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007
This deviceK140216 Orthopedic Fixation SystemsImpact Medical, LLC · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K761228	Luhr Mandibular Compression-Screw System	Howmedica Corp.	1976	—
−6	K963739	Leibinger - Luhr Small Orthopedic Bone Screws	Howmedica Leibinger, Inc.	1997	—
−5	K970912	Leibinger Self-Drilling Screw	Howmedica Leibinger, Inc.	1997	—
−4	K974785	Auto-Drive Bone Screw	Osteomed Corp.	1998	—
−3	K023260	1.2MM Osteomed Auto-Drive Screw System	Osteomed Corp.	2002	—
−2	K063589	Gso Bone Fixation Fasteners	Gold Standard Orthopaedics, LLC	2007	—
−1	K071035	Ifs Bone Fixation Devices	Internal Fixation Systems, Inc.	2007	—
0 (this device)	K140216	Orthopedic Fixation Systems	Impact Medical, LLC	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	2	0
1988	2	0
1989	1	0
1990	1	0
1991	3	0
1994	2	0
1995	4	0
1996	7	0
1997	4	0
1998	4	0
1999	3	0
2000	4	0
2001	4	0
2002	4	0
2004	2	0
2005	6	0
2006	4	0
2007	2	0
2008	3	0
2009	1	0
2010	1	0
2011	1	0

FIG. 1 — Lineage of K140216, 1976–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (7)

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	Applicant	Decided	Recalls
*	K110086	Ifs Profile Plates, Screws, and Washers Summary page 1 …n fastener Classification: Class 11 Classification Panel: Orthopedics Legally Marketed Predicate Device (s) 510(k)ys: K110086, K962011,.K071035, K061620, K000684, K043185, K021556 Im ac…	Internal Fixation Systems, Inc.	2011	—
*	K962011	Synthes 7.0/7.3 MM Cannulated Screws Summary page 1 …r Classification: Class 11 Classification Panel: Orthopedics Legally Marketed Predicate Device (s) 510(k)ys: K110086, K962011,.K071035, K061620, K000684, K043185, K021556 Im ac(140216…	Synthes (Usa)	1996	—
*	K071035	Ifs Bone Fixation Devices Summary page 1 …fication: Class 11 Classification Panel: Orthopedics Legally Marketed Predicate Device (s) 510(k)ys: K110086, K962011,.K071035, K061620, K000684, K043185, K021556 Im ac(140216…	Internal Fixation Systems, Inc.	2007	—
*	K061620	Ifs Cannulated Bone Screw Summary page 1 …Class 11 Classification Panel: Orthopedics Legally Marketed Predicate Device (s) 510(k)ys: K110086, K962011,.K071035, K061620, K000684, K043185, K021556 Im ac(140216…	Internal Fixation Systems, Inc.	2006	—
*	K000684	Small Fragment Dynamic Compression Locking (DCL) System Summary page 1 …Class 11 Classification Panel: Orthopedics Legally Marketed Predicate Device (s) 510(k)ys: K110086, K962011,.K071035, K061620, K000684, K043185, K021556 Im ac(140216…	Synthes (Usa)	2000	1
*	K043185	Synthes 3.5MM Cortex Screws Summary page 1 …s 11 Classification Panel: Orthopedics Legally Marketed Predicate Device (s) 510(k)ys: K110086, K962011,.K071035, K061620, K000684, K043185, K021556 Im ac(140216…	Synthes (Usa)	2005	—
*	K021556	Synthes 2.4 MM Cannulated Compression Screw Summary page 1 …ssification Panel: Orthopedics Legally Marketed Predicate Device (s) 510(k)ys: K110086, K962011,.K071035, K061620, K000684, K043185, K021556 Im ac(140216…	Synthes (Usa)	2002	—

Also cleared against K110086: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 38 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
11 of the 72 ancestors have a recall of any class.
3 other devices also cite its predicate K110086.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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	—

What is it indicated for?

The Impact Medical, ZIG screws, plates, k-wires and are single use, non-sterile and are indicated

for use in:

fixation and stabilization of fractures in small and long bones: including at a minimum: the

tibia .fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle,

humerus, ulna, middle hand and middle foot bones, calcaneus and for fixation of fractures in

the proximal femur and trochanteric, pertrochanteric , intertrochanter ic, and basilar neck

fractures

Kirschner (K) wires are used in support of fracture fixation, for osteotomies in the presence

of adequate immobilization and implant guide wires

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140216 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140216: Orthopedic Fixation Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140216

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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