510(k) · Cleared

Recalled · Class II · 2013

Blackstone Pedicle Screw System

K081684510(k) TraditionalCleared Sep 15, 200890-day reviewClass II21 CFR 888.3070Recalls 3

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

Blackstone Medical, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Sep 15, 2008 as substantially equivalent to K994217 (Blackstone Medical, Inc., 2000) and 9 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1998. 277 later devices descend from it. It has been recalled 3 times.

Decided: Sep 15, 2008
Review: 90 days
Class: Class II
Product code: NKB
Recalls: 3
Predicates: 10

Its longest line of descent runs back 5 generations to K980447 (1998). 20 ancestors in all. 277 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 5 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
4 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
3 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
2 generations backK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
1 generation backK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
This deviceK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
Descendant · cites it directly · 209 of its ownK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
Descendant · cites it directly · 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
Descendant · 2 generations on · 92 of its ownK100623 Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · Recalled

Showing 5 of 277 descendants. See all descendants

Descendants cleared per year

2008high 35 (2023) · low 1 (2008)2026

Most influential descendants

Showing 5 of 277 · See all

K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · cites it directly209descendants
K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · cites it directly130descendants
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
K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · 2 generations on92descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K980447	Depuy Motech Moss Miami Spinal System	DePuy Orthopaedics, Inc.	1998	—
−4	K013558	Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw	Blackstone Medical, Inc.	2002	—
−3	K022399	Blackstone Spinal Fixation System Spacer	Blackstone Medical, Inc.	2002	—
−2	K030241	Modification to Blackstone Spinal Fixation System	Blackstone Medical, Inc.	2003	—
−1	K080407	Blackstone SFS Parallel Rod Connectors	Blackstone Medical, Inc.	2008	1
0 (this device)	K081684	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	—
+1	K082797	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	—
+1	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	—
+2	K100623	Aesculap Implant Systems S4 Spinal System	Aesculap Implant Systems	2010	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2000	2	0
2001	1	0
2002	4	0
2003	3	0
2005	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	4	0
2011	2	0
2012	5	0
2013	9	0
2014	4	0
2015	8	0
2016	11	0
2017	20	0
2018	14	0
2019	17	0
2020	19	0
2021	15	0
2022	21	0
2023	35	0
2024	33	0
2025	33	0
2026	25	0

FIG. 1 — Lineage of K081684, 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 NKB? 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 NKB device

#1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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? (10)

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
*	K994217	Blackstone Spinal Fixation System Summary page 2 …Orthopedic Device Panel Predicate Devices: Blackstone Medical, Inc. Spinal Fixation System (SFS): * Blackstone SFS (K994217 SE 2-28-00) * Blackstone SFS 4.5mm Multi-Axial Screws…	Blackstone Medical, Inc.	2000	—
*	K020674	Blackstone Spinal Fixation System 4.5MM Multi-Axial Screw Summary page 2 …* Blackstone SFS (K994217 SE 2-28-00) * Blackstone SFS 4.5mm Multi-Axial Screws (K020674 SE 4-3-02) · Blackstone SFS 4.5mm Mono-Axial Screws (…	Blackstone Medical, Inc.	2002	—
*	K013558	Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw Summary page 2 …(K020674 SE 4-3-02) · Blackstone SFS 4.5mm Mono-Axial Screws (K013558 SE 1-23-02) * Blackstone SFS 2nd Gen. Cross-Connector…	Blackstone Medical, Inc.	2002	—
*	K003735	Blackstone Spinal Fixation System, Second-Generation Cross-Connector Summary page 2 …(K013558 SE 1-23-02) * Blackstone SFS 2nd Gen. Cross-Connector (K003735 SE 5-8-01) * Blackstone SFS Modified Multi-Axial Screws…	Blackstone Medical, Inc.	2001	—
*	K023498	Modification to Blackstone Spinal Fixation System Summary page 2 …(K003735 SE 5-8-01) * Blackstone SFS Modified Multi-Axial Screws (K023498 SE 11-13-02) * Blackstone SFS Lateral Offset Components…	Blackstone Medical, Inc.	2002	—
*	K030581	Blackstone Spinal Fixation System Lateral Offset (System Modification) Summary page 2 …(K023498 SE 11-13-02) * Blackstone SFS Lateral Offset Components (K030581 SE 6-26-03) * Blackstone SFS Rigid Cross Connector (…	Blackstone Medical, Inc.	2003	—
*	K030862	Blackstone Spinal Fixation System Rigid Cross Connector Summary page 2 …(K030581 SE 6-26-03) * Blackstone SFS Rigid Cross Connector (K030862 SE 4-17-03) * Blackstone SFS Parallel Rod Connectors…	Blackstone Medical, Inc.	2003	—
*	K080407	Blackstone SFS Parallel Rod Connectors Summary page 2 …(K030862 SE 4-17-03) * Blackstone SFS Parallel Rod Connectors (K080407 SE 3-13-08) * Synthes Pangea Spine System (K052123 SE 9/23/05…	Blackstone Medical, Inc.	2008	1
*	K052123	Synthes Pangea System Summary page 2 …* Blackstone SFS Parallel Rod Connectors (K080407 SE 3-13-08) * Synthes Pangea Spine System (K052123 SE 9/23/05 & K052151 SE 12-7-05) Intended Use / Indications for Use The Blackstone Pedi…	Synthes (Usa)	2005	—
*	K052151	Synthes Pangea Monoaxial System Summary page 2 …(K080407 SE 3-13-08) * Synthes Pangea Spine System (K052123 SE 9/23/05 & K052151 SE 12-7-05) Intended Use / Indications for Use The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedi…	Synthes Spine Co.Lp	2005	—

Also cleared against K994217: 9 other devices →

What descends from it? (277)

See all 277

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

Number	Device	Applicant	Decided	Descendants
K082797	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	209
K092624	Firebird Spinal Fixation System	Blackstone Medical, Inc.	2009	130
K100044	Firebird Spinal Fixation System, Firebird Side-Loading Body	Blackstone	2010	117
K102204	Choice Spine Starfire Pedicle Screw System	Choicespine, LP	2010	88
K093926	Firebird Spinal Fixation System	Blackstone Medical, Inc.	2010	88
K130932	Firebird Spinal Fixation System	Orthofix, Inc.	2013	81
K111448	Icon (TM) Modular Pedicle Screw System	Orthofix, Inc.	2012	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 26, 2013	Class II	Z-0855-2014	Nonconforming Material/Component	Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction…
Oct 22, 2010	Not classified	Z-1674-2011	Other	There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.
Oct 22, 2010	Not classified	Z-1608-2011	Other	There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.

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 7 months on median.
2 of the 20 ancestors have a recall of any class.
Of its descendants, K082797 (Blackstone Medical, Inc., 2008) has gone furthest, with 209 descendants of its own.
9 other devices also cite its predicate K994217.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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	38	87	4	34
2008	36	59	5	82
2009	44	71	33	171
2010	37	111	4	462
2011	48	84	3	577
2012	60	79	13	1,747
2013	35	73	0	1,962
2014	46	90	3 (1)	1,671
2015	55	90	3	1,446
2016	50	84	1	1,585
2017	63	69	1	1,618
2018	56	61	3	1,684
2019	39	84	1	1,915
2020	48	68	1	2,076
2021	32	61	0	1,745
2022	34	88	5	1,339
2023	44	72	2	919
2024	39	57	3	1,614
2025	24	61	1	1,171
2026	30	91	3	—

What is it indicated for?

The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications regardless of the intended use: 1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and…

Read the full statement (122 words)

1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

2) spondylolisthesis,

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

4) spinal stenosis,

5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

6) tumor,

7) pseudoarthrosis, and

8) failed previous fusion

The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081684 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081684: Blackstone Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081684

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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