510(k) · Cleared
ClearedSouthern Transforaminal Lumbar Interbody Fusion (TLIF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Medical (Pty), Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 8, 2022 as substantially equivalent to K150061 (Spinal Elements, Inc., 2015) and 5 other predicates after a 227-day review. Its family tree reaches back 22 generations to 1984. 1 of the 334 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 8, 2022
- Review
- 227 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 22 generations to K841189 (1984). 333 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 334 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK221182 Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd. · 2022
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK221182 Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd. · 2022
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty), Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 12 | 0 |
| 2002 | 11 | 0 |
| 2003 | 18 | 0 |
| 2004 | 28 | 0 |
| 2005 | 21 | 0 |
| 2006 | 11 | 0 |
| 2007 | 18 | 0 |
| 2008 | 43 | 1 |
| 2009 | 30 | 0 |
| 2010 | 17 | 0 |
| 2011 | 24 | 0 |
| 2012 | 15 | 0 |
| 2013 | 15 | 0 |
| 2014 | 12 | 0 |
| 2015 | 10 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 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.
1 device in this family has a Class I recall. 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K150061 | Lucent; Lucent Ti-Bond SystemsSummary page 5…or Model Name Manufacturer Product Predicate Number Code Type K150061 LUCENT®, LUCENT Ti-BOND® Spinal Elements, Inc. MAX Primary K171657, ShurFit 2C Lumbar In… | 2015 |
| * | K171657 | ShurFit 2C Lumbar Interbody Fusion SystemSummary page 5…Code Type K150061 LUCENT®, LUCENT Ti-BOND® Spinal Elements, Inc. MAX Primary K171657, ShurFit 2C Lumbar Interbody Fusion Precision Spine, Inc. MAX Additional K092193 (originally Spina… | 2017 |
| * | K092193 | Spinal Usa Interbody CagesSummary page 5…Spinal Elements, Inc. MAX Primary K171657, ShurFit 2C Lumbar Interbody Fusion Precision Spine, Inc. MAX Additional K092193 (originally Spinal USA Intervertebral Body (formerly Spinal USA) Fusion Device) K172341 NuVasive® M… | 2009 |
| * | K172341 | NuVasive® Modulus TLIF Interbody SystemSummary page 5…Precision Spine, Inc. MAX Additional K092193 (originally Spinal USA Intervertebral Body (formerly Spinal USA) Fusion Device) K172341 NuVasive® Modulus TLIF Interbody NuVasive, Inc. MAX, Additional System… | 2017 |
| * | K113561 | TM Ardis Interbody System TM Ardis Interbody System InstrumenationSummary page 5…odulus TLIF Interbody NuVasive, Inc. MAX, Additional System PHM K113561 TM Ardis® Interbody System Zimmer Trabecular MAX Additional… | 2012 |
| * | K133614 | Aleutian Ibf SystemSummary page 5…dis® Interbody System Zimmer Trabecular MAX Additional Metal Technology, Inc. K133614 Aleutian IBF System (Lumbar) K2M, Inc. MAX Additional PERFORMANCE DATA The Southern T… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 44 of the 333 ancestors have a recall of any class; 1 has a Class I recall.
- 9 other devices also cite its predicate K150061.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft…
Read the full statement (158 words)
The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft to facilitate fusion.
The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221182 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221182: Southern Transforaminal Lumbar Interbody Fusion (TLIF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221182
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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