510(k) · Cleared

Cleared

Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba Screw, 9MM D

K121148510(k) TraditionalCleared Aug 20, 2012126-day reviewClass II21 CFR 888.3040

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

Medical Design, LLC · HWC Screw, Fixation, Bone

Cleared on Aug 20, 2012 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 1 other predicate after a 126-day review. Its family tree reaches back 6 generations to 1990. 35 later devices descend from it.

Decided: Aug 20, 2012
Review: 126 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 6 generations to K903810 (1990). 11 ancestors in all. 35 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 6 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
5 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
4 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
3 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
2 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
1 generation backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
This deviceK121148 Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long…Medical Design, LLC · 2012
Descendant · cites it directly · 31 of its ownK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
Descendant · 2 generations on · 29 of its ownK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
Descendant · 3 generations on · 26 of its ownK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
Descendant · 4 generations on · 25 of its ownK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
Descendant · 5 generations on · 19 of its ownK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2018high 7 (2022) · low 1 (2018)2026

Most influential descendants

Showing 5 of 35 · See all

K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019 · cites it directly31descendants
K200696FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · 2 generations on29descendants
K201664FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · 3 generations on26descendants
K203138FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · 4 generations on25descendants
K210667FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021 · 5 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K903810	Ace Cannulated Self Tapping Cancellous Bone Screw	Ace Medical Co.	1990	—
−5	K051296	Sijf Cannulated Screw System	Depuy Spine, Inc.	2005	—
−4	K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2010	—
−3	K110512	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
−2	K111801	Simmetry (TM) Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
−1	K112028	SI-Lok Sacroiliac Joint Fixation System	Globus Medical, Inc.	2011	—
0 (this device)	K121148	Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba…	Medical Design, LLC	2012	—
+1	K183342	SambaScrew 3D SI Fusion System	Orthofix, Inc.	2019	—
+2	K200696	FIREBIRD SI Fusion System	Orthofix, Inc.	2020	1
+3	K201664	FIREBIRD SI Fusion System	Orthofix, Inc.	2020	—
+4	K203138	FIREBIRD SI Fusion System	Orthofix, Inc.	2020	—
+5	K210667	FIREBIRD SI Fusion System	Orthofix, Inc.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2000	1	0
2002	2	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2019	1	0
2020	3	0
2021	4	0
2022	7	0
2023	7	0
2024	2	0
2025	5	0
2026	5	0

FIG. 1 — Lineage of K121148, 1990–2026Source: 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 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

Get a 510(k) Report

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
*	K021932	Synthes 6.5 MM Cannulated Screw Summary page 1 …ct Code: HWC, OUR Predicate Device(s): The subject device is equivalent to the following devices: * Synthes 6.5mm Cannulated Screw (K02 1932) * SI-LOK Sacroiliac Joint Fixation System (KI 12028) Device Description: The SAMBA screw is a cann…	Synthes (Usa)	2002	7
*	K112028	SI-Lok Sacroiliac Joint Fixation System	Globus Medical, Inc.	2011	—

Also cleared against K021932: 61 other devices →

What descends from it? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K183342	SambaScrew 3D SI Fusion System	Orthofix, Inc.	2019	31
K213590	Blue Topaz Sacroiliac Screw System	Osseus Fusion Systems, LLC	2022	1
K203780	Harvester SI: Sacroiliac Fixation System	Spinus International, Inc.	2021	0
K173752	SI Screw System	Zavation Medical Products, LLC	2018	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 22 years and passes through 5 companies; a new generation was cleared every 8 months on median.
2 of the 11 ancestors have a recall of any class.
Of its descendants, K183342 (Orthofix, Inc., 2019) has gone furthest, with 31 descendants of its own.
61 other devices also cite its predicate K021932.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)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?

The SAMBATM Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121148: Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba Screw, 9MM D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121148

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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