510(k) · Cleared

Cleared

Skaffold Cis

K111538510(k) TraditionalCleared Oct 25, 2011145-day reviewClass U

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

Cleared on Oct 25, 2011 as substantially equivalent to K971680 (United States Surgical, A Division of Tyco Healthc, 1997) and 2 other predicates after a 145-day review. Its family tree reaches back 6 generations to 1979. 18 later devices descend from it.

Decided: Oct 25, 2011
Review: 145 days
Class: Class U
Product code: MTJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 6 generations to K791495 (1979). 11 ancestors in all. 18 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 6 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
5 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
4 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
3 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
2 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
1 generation backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
This deviceK111538 Skaffold CisSkeletal Kinetics, LLC · 2011
Descendant · cites it directly · 16 of its ownK123243 Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2013
Descendant · cites it directly · 13 of its ownK141502 HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014
Descendant · 2 generations on · 12 of its ownK152005 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015
Descendant · 3 generations on · 3 of its ownK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
Descendant · 3 generations on · 3 of its ownK191140 MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc. · 2019

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2013high 4 (2023) · low 0 (2017)2026

Most influential descendants

Showing 5 of 18 · See all

K123243Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2013 · cites it directly16descendants
K141502HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014 · cites it directly13descendants
K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015 · 2 generations on12descendants
K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023 · 3 generations on3descendants
K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc. · 2019 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K791495	Lukens Bone Wax (Gamma Radiation)	Lukens Corp.	1979	—
−5	K971680	Auto Suture Bone Wax	United States Surgical, A Division of Tyco Healthc	1997	—
−4	K041363	Aoc Bone Wax	Ceremed, Inc.	2004	1
−3	K050440	Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12	Ceremed, Inc.	2005	—
−2	K052528	Aoc Bone Wax Ostene, Osteotene and Ceretene	Ceremed, Inc.	2005	—
−1	K062280	Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste	Ceremed, Inc.	2006	—
0 (this device)	K111538	Skaffold Cis	Skeletal Kinetics, LLC	2011	—
+1	K123243	Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2013	—
+1	K141502	HBP4 Hardening, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2014	—
+2	K152005	MONTAGE Settable, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2015	—
+3	K213418	MONTAGE Settable, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2023	—
+3	K191140	MONTAGE-QS Settable, Resorbable Hemostatic Bone	Orthocon, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
2002	2	0
2004	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	2	0
2015	2	0
2016	1	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2023	4	0
2024	2	0
2026	2	0

FIG. 1 — Lineage of K111538, 1979–2026Source: 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 MTJ? 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 MTJ device

#1 K262769 Permatage XT Settable Nonabsorbable Hemostatic…score 15.5 · 13 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? (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	Applicant	Decided	Recalls
*	K971680	Auto Suture Bone Wax Summary page 1 …The subject device is substantially equivalent in safety and effectiveness to the following legally marketed devices (predicates): 1. Auto Suture Bone Wax K97 1680 IL. Ostene K062280 111. Ethicon Bone Wax Preamendment IV. Lukens Bone Wax…	United States Surgical, A Division of Tyco Healthc	1997	—
*	K062280	Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste Summary page 1 …in safety and effectiveness to the following legally marketed devices (predicates): 1. Auto Suture Bone Wax K97 1680 IL. Ostene K062280 111. Ethicon Bone Wax Preamendment IV. Lukens Bone Wax K791495 Device Description as required…	Ceremed, Inc.	2006	—
*	K791495	Lukens Bone Wax (Gamma Radiation) Summary page 1 …Suture Bone Wax K97 1680 IL. Ostene K062280 111. Ethicon Bone Wax Preamendment IV. Lukens Bone Wax K791495 Device Description as required by 21 CFR 807.92 (a) (4) The single use CAAP (Calcium Apatite) Bone Wax sterile kit contains: Cal…	Lukens Corp.	1979	—
*	—	Ethicon Bone Wax Named without a submission number			—

Also cleared against K971680: 7 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K123243	Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2013	16
K141502	HBP4 Hardening, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2014	13
K142348	OsteoSeal Bone Hemostat	Hemostasis, LLC	2015	0

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 32 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
3 of the 11 ancestors have a recall of any class.
Of its descendants, K123243 (Orthocon, Inc., 2013) has gone furthest, with 16 descendants of its own.
7 other devices also cite its predicate K971680.

How does its category compare?

All MTJ devices

MTJ Wax, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MTJ

4in 2023

2007high 5 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MTJ

370in 2023

2007high 370 (2023) · low 46 (2014)2026

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

Recalls per year · MTJ

1in 2023

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · MTJ

22in 2025

2007high 32 (2024) · low 0 (2009)2025

MAUDE reports naming product code MTJ, 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	0	—	0	2
2008	1	—	1	1
2009	2	—	0	0
2010	1	—	0	0
2011	5	140	0	2
2012	3	141	0	8
2013	2	—	0	5
2014	4	46	0	6
2015	2	—	0	11
2016	2	—	0	7
2017	0	—	0	7
2018	0	—	0	12
2019	1	—	0	17
2020	1	—	0	16
2021	1	—	0	12
2022	1	—	0	31
2023	4	370	1	20
2024	0	—	0	32
2025	0	—	0	22
2026	2	—	0	—

What is it indicated for?

CAAP (Calcium Apatite) Bone Wax is indicated to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111538: Skaffold Cis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111538

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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