510(k) · Cleared

Recalled · Class II · 2013

Blackstone SFS Parallel Rod Connectors

K080407510(k) SpecialCleared Mar 13, 200828-day reviewClass II21 CFR 888.3070Recalls 1

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

Blackstone Medical, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Mar 13, 2008 as substantially equivalent to K994217 (Blackstone Medical, Inc., 2000) and 9 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1998. 296 later devices descend from it. It has been recalled once.

Decided: Mar 13, 2008
Review: 28 days
Class: Class II
Product code: MNI
Recalls: 1
Predicates: 11

Its longest line of descent runs back 4 generations to K980447 (1998). 14 ancestors in all. 296 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 4 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
3 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
2 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
1 generation backK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
This deviceK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008
Descendant · cites it directly · 277 of its ownK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
Descendant · 2 generations on · 209 of its ownK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
Descendant · 2 generations on · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
Descendant · cites it directly · 117 of its ownK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
Descendant · 2 generations on · 116 of its ownK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012

Showing 5 of 296 descendants. See all descendants

Descendants cleared per year

2008high 36 (2023) · low 1 (2009)2026

Most influential descendants

Showing 5 of 296 · See all

K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · cites it directly277descendants
K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · 2 generations on209descendants
K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · 2 generations on130descendants
K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010 · cites it directly117descendants
K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012 · 2 generations on116descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K980447	Depuy Motech Moss Miami Spinal System	DePuy Orthopaedics, Inc.	1998	—
−3	K013558	Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw	Blackstone Medical, Inc.	2002	—
−2	K022399	Blackstone Spinal Fixation System Spacer	Blackstone Medical, Inc.	2002	—
−1	K030241	Modification to Blackstone Spinal Fixation System	Blackstone Medical, Inc.	2003	—
0 (this device)	K080407	Blackstone SFS Parallel Rod Connectors	Blackstone Medical, Inc.	2008	—
+1	K081684	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	3
+2	K082797	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	—
+2	K092624	Firebird Spinal Fixation System	Blackstone Medical, Inc.	2009	1
+1	K100044	Firebird Spinal Fixation System, Firebird Side-Loading Body	Blackstone	2010	—
+2	K122901	Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System	Orthofix	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2002	4	0
2003	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2009	1	0
2010	4	0
2011	2	0
2012	5	0
2013	9	0
2014	5	0
2015	9	0
2016	12	0
2017	23	0
2018	16	0
2019	17	0
2020	23	0
2021	16	0
2022	23	0
2023	36	0
2024	33	0
2025	34	0
2026	26	0

FIG. 1 — Lineage of K080407, 1998–2026Source: 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (11)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K994217	Blackstone Spinal Fixation System Summary page 1 …System MNI - 888.3070 - Pedicle Screw Spinal System Substantially Equivalent Devices: BlackstoneTM SFS (K994217 SE 2-28-00) BlackstoneTM SFS 4.5mm Multi-Axial Screws (K020674 SE 4-3-02) BlackstoneTM SES 4.5mm Mono-Axial Scr…	Blackstone Medical, Inc.	2000	—
*	K020674	Blackstone Spinal Fixation System 4.5MM Multi-Axial Screw Summary page 1 …3070 - Pedicle Screw Spinal System Substantially Equivalent Devices: BlackstoneTM SFS (K994217 SE 2-28-00) BlackstoneTM SFS 4.5mm Multi-Axial Screws (K020674 SE 4-3-02) BlackstoneTM SES 4.5mm Mono-Axial Screws (K0I13558 SE 1-23-02) BlackstoneTM SFS 2nd Gen. Cross-Conne…	Blackstone Medical, Inc.	2002	—
Kept off the family tree	K011358	Blackstone SES 4.5mm Mono-Axial Screws Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*	K003735	Blackstone Spinal Fixation System, Second-Generation Cross-Connector Summary page 1 …4.5mm Multi-Axial Screws (K020674 SE 4-3-02) BlackstoneTM SES 4.5mm Mono-Axial Screws (K0I13558 SE 1-23-02) BlackstoneTM SFS 2nd Gen. Cross-Connector (K003735 SE 5-8-0 1) BlackstoneTM SFS Modified Multi-Axial Screws (K023498 SE 11-13-02) BlackstoneTM SF5 Hooks (K013885…	Blackstone Medical, Inc.	2001	—
*	K023498	Modification to Blackstone Spinal Fixation System Summary page 1 …mm Mono-Axial Screws (K0I13558 SE 1-23-02) BlackstoneTM SFS 2nd Gen. Cross-Connector (K003735 SE 5-8-0 1) BlackstoneTM SFS Modified Multi-Axial Screws (K023498 SE 11-13-02) BlackstoneTM SF5 Hooks (K013885 SE 2-1-02) BlackstoneTM SFS Spacers (K022399 SE 8-6-02) B…	Blackstone Medical, Inc.	2002	—
*	K013885	Blackstone Spinal Fixation System Posterior Hooks Summary page 1 …ackstoneTM SFS 2nd Gen. Cross-Connector (K003735 SE 5-8-0 1) BlackstoneTM SFS Modified Multi-Axial Screws (K023498 SE 11-13-02) BlackstoneTM SF5 Hooks (K013885 SE 2-1-02) BlackstoneTM SFS Spacers (K022399 SE 8-6-02) BlackstoneTM SFS Staple & Washer (K022605 SE 8-21-02)…	Blackstone Medical, Inc.	2002	—
*	K022399	Blackstone Spinal Fixation System Spacer Summary page 1 …8-0 1) BlackstoneTM SFS Modified Multi-Axial Screws (K023498 SE 11-13-02) BlackstoneTM SF5 Hooks (K013885 SE 2-1-02) BlackstoneTM SFS Spacers (K022399 SE 8-6-02) BlackstoneTM SFS Staple & Washer (K022605 SE 8-21-02) Blackstone TMN SFS Axial Domino (K030241 SE 2-…	Blackstone Medical, Inc.	2002	—
*	K022605	Blackstone Spinal Fixation System Staple & Washer Summary page 1 …K023498 SE 11-13-02) BlackstoneTM SF5 Hooks (K013885 SE 2-1-02) BlackstoneTM SFS Spacers (K022399 SE 8-6-02) BlackstoneTM SFS Staple & Washer (K022605 SE 8-21-02) Blackstone TMN SFS Axial Domino (K030241 SE 2-21-03) BlackstoneTM SES Rigid Cross Connector (K03086…	Blackstone Medical, Inc.	2002	—
*	K030241	Modification to Blackstone Spinal Fixation System Summary page 1 …SE 2-1-02) BlackstoneTM SFS Spacers (K022399 SE 8-6-02) BlackstoneTM SFS Staple & Washer (K022605 SE 8-21-02) Blackstone TMN SFS Axial Domino (K030241 SE 2-21-03) BlackstoneTM SES Rigid Cross Connector (K030862 SE 4-17-03) BlackstoneTM SES Lateral Offset (K03058…	Blackstone Medical, Inc.	2003	—
*	K030862	Blackstone Spinal Fixation System Rigid Cross Connector Summary page 1 …BlackstoneTM SFS Staple & Washer (K022605 SE 8-21-02) Blackstone TMN SFS Axial Domino (K030241 SE 2-21-03) BlackstoneTM SES Rigid Cross Connector (K030862 SE 4-17-03) BlackstoneTM SES Lateral Offset (K030581 SE 6-26-03) Device Description: The Blackstone Spinal Fixation Sy…	Blackstone Medical, Inc.	2003	—
*	K030581	Blackstone Spinal Fixation System Lateral Offset (System Modification) Summary page 1 …Blackstone TMN SFS Axial Domino (K030241 SE 2-21-03) BlackstoneTM SES Rigid Cross Connector (K030862 SE 4-17-03) BlackstoneTM SES Lateral Offset (K030581 SE 6-26-03) Device Description: The Blackstone Spinal Fixation System (SFS) is comprised of titanium alloy (Ti-6AL-4V ELI per A…	Blackstone Medical, Inc.	2003	—

Also cleared against K994217: 9 other devices →

What descends from it? (296)

See all 296

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

Number	Device	Applicant	Decided	Descendants
K081684	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	277
K100044	Firebird Spinal Fixation System, Firebird Side-Loading Body	Blackstone	2010	117
K093926	Firebird Spinal Fixation System	Blackstone Medical, Inc.	2010	88
K171082	Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…	Orthofix, Inc.	2017	61
K170647	Connector System	Orthofix, Inc.	2017	18
K140260	Skyhawk Lateral Plate System	Orthofix, Inc.	2014	14
K150184	Dymaxeon Spine System	Back 2 Basics Direct, LLC	2015	4
K211710	Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…	Orthofix, Inc.	2021	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 1, 2013	Class II	Z-0896-2013	Device Design	There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
None of the 14 ancestors has a recall.
Of its descendants, K081684 (Blackstone Medical, Inc., 2008) has gone furthest, with 277 descendants of its own.
9 other devices also cite its predicate K994217.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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	20	82	26	83
2008	23	64	8	108
2009	18	86	3	138
2010	16	74	1	126
2011	17	111	0	146
2012	19	75	1	200
2013	14	77	4	824
2014	6	104	0	301
2015	12	54	1	260
2016	7	168	0	117
2017	1	—	0	247
2018	0	—	1	134
2019	0	—	0	188
2020	0	—	0	115
2021	0	—	0	270
2022	0	—	0	214
2023	0	—	0	122
2024	0	—	0	114
2025	0	—	0	80
2026	0	—	0	—

What is it indicated for?

The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients: a) Having severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the device…

Read the full statement (301 words)

The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

a) Having severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint;

b) Who are receiving fusion using autogenous bone graft only;

c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and

d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

a) Degenerative spondylolistheses with objective evidence of neurologic impainnent;

b) Fracture;

c) Dislocation;

d) Scoliosis;

e) Kyphosis;

f) Spinal tumor; and

g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);

b) spondylolistheses;

c) spinal stenosis;

d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);

e) tumor;

f) pseudoarthrosis;

g) previous failed fusion; and

h) trauma (i.e., fracture or dislocation).

The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);

b) spondylolistheses;

c) spinal stenosis;

d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);

e) tumor;

f) pseudoarthrosis;

g) previous failed fusion; and

h) trauma (i.e., fracture or dislocation)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080407 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080407: Blackstone SFS Parallel Rod Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080407

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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