510(k) · Cleared

Cleared

Cranial Remolding Orthosis

K111247510(k) TraditionalCleared Aug 15, 2011104-day reviewClass II21 CFR 882.5970

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

Orthotic Care Services, Llp · MVA Orthosis, Cranial

Cleared on Aug 15, 2011 as substantially equivalent to K082950 (Orthomerica Products, Inc., 2008) and 1 other predicate after a 104-day review. Its family tree reaches back 4 generations to 2000.

Decided: Aug 15, 2011
Review: 104 days
Class: Class II
Product code: MVA
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K001167 (2000). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
3 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
2 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
1 generation backK082950 StarbandOrthomerica Products, Inc. · 2008
This deviceK111247 Cranial Remolding OrthosisOrthotic Care Services, Llp · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K001167	Opi Band	Orthomerica Products, Inc.	2000	—
−3	K021207	Starlight	Orthomerica Products, Inc.	2002	—
−2	K081994	Starlight	Orthomerica Products, Inc.	2008	—
−1	K082950	Starband	Orthomerica Products, Inc.	2008	—
0 (this device)	K111247	Cranial Remolding Orthosis	Orthotic Care Services, Llp	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K111247, 2000–2011Source: 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 MVA? 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 MVA device

#1 K230444 Talee, Talee PostOpscore 11.8 · 12 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? (2)

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
*	K082950	Starband Summary page 1 …lass 11,Cranial Orthosis, Code MVA Classification Name: Cranial Orthosis ( 21 C.F.R. § 882.5970) 3.) Predicate Devices: STARband Cranial Remolding Orthosis (K082950/K011350) 510(k) submitter: Orthomerica Products Inc, 505 31st Street, P.O. Box 2927, Newport Beach, CA 92659, Telephone: (949) 72…	Orthomerica Products, Inc.	2008	—
*	K011350	Starband Cranial Orthosis Summary page 1 …Cranial Orthosis, Code MVA Classification Name: Cranial Orthosis ( 21 C.F.R. § 882.5970) 3.) Predicate Devices: STARband Cranial Remolding Orthosis (K082950/K011350) 510(k) submitter: Orthomerica Products Inc, 505 31st Street, P.O. Box 2927, Newport Beach, CA 92659, Telephone: (949) 723-4500,…	Orthomerica Products, Inc.	2001	—

Also cleared against K082950: 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 11 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
None of the 5 ancestors has a recall.
3 other devices also cite its predicate K082950.

How does its category compare?

All MVA devices

MVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MVA

1in 2024

2007high 3 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVA

209in 2022

2007high 209 (2022) · low 104 (2011)2026

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

Recalls per year · MVA

No recall names MVA since 2007.

Adverse event reports per year · MVA

1in 2022

2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code MVA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	0	—	1
2009	0	—	1
2010	1	—	2
2011	3	104	0
2012	0	—	0
2013	0	—	0
2014	3	114	0
2015	0	—	1
2016	0	—	1
2017	0	—	3
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	2	—	0
2022	3	209	1
2023	2	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months

with moderate to severe nonsynostotic positional plagiocephaly, including infants with

plagiocephalic, scaphocephalic, and brachycephalic-shaped heads, by applying pressure to

prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.

The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery

for infants between 3-18 months with craniosynostosis who still need moderate to severe

correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped

heads.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111247 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111247: Cranial Remolding Orthosis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111247

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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