510(k) · Cleared
ClearedGPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gpc Medical Limited · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 31, 2017 as substantially equivalent to K100685 (Alphatec Spine, Inc., 2010) and 1 other predicate after a 147-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Mar 31, 2017
- Review
- 147 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K901587 (1990). 57 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 5 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 4 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 3 generations backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- 2 generations backK020245 Modification to Isobar Spinal SystemScien'Tx USA, Inc. · 2002
- 1 generation backK042964 MX Monoaxial Pedicle ScrewScient'X · 2004
- This deviceK163096 GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −6 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −5 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −4 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −3 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| −2 | K020245 | Modification to Isobar Spinal System | Scien'Tx USA, Inc. | 2002 | — |
| −1 | K042964 | MX Monoaxial Pedicle Screw | Scient'X | 2004 | — |
| 0 (this device) | K163096 | GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System | Gpc Medical Limited | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K100685 | Zodiac Polyaxial Spinal Fixation SystemSummary page 6…Additional Predicates 01 GPC BRAND Posterior,Zodiac Polyaxial Spinal Fixation Scient’X MX Monoaxial Pedicle Non cervical Pedicle System (K100685) Screw System (K042964) Screw Spinal System a4).A description of the device that is the subject… | 2010 |
| * | K042964 | MX Monoaxial Pedicle ScrewSummary page 6…GPC BRAND Posterior,Zodiac Polyaxial Spinal Fixation Scient’X MX Monoaxial Pedicle Non cervical Pedicle System (K100685) Screw System (K042964) Screw Spinal System a4).A description of the device that is the subject to the premarket notification submis… | 2004 |
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 27 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 57 ancestors have a recall of any class.
- 7 other devices also cite its predicate K100685.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 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 GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients. 1. Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by…
Read the full statement (112 words)
The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients.
1. Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies)
2. Spondylolisthesis
3. Trauma (Fracture or Dislocation)
4. Spinal Stenosis
5. Scoliosis, kyphosis and/or lordosis
6. Pseudoarthrosis
7. Failed Previous Fusion
The system is indicated for use in adult patients only. All implants are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163096: GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163096
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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